Trial Outcomes & Findings for Concomitant Use of Gardasil (V501, Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) With Combined Diptheria, Tetanus, Pertussis and Poliomyelitis Vaccine in Adolescents (V501-024)(COMPLETED) (NCT NCT00337428)
NCT ID: NCT00337428
Last Updated: 2016-11-16
Results Overview
Serum antibodies to HPV Type 6 were measured with a Competitive Luminex Immunoassay. Titers were reported in milli Merck Units (mMU)/milliliter (mL). GMTs from participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared GMTs for each HPV type using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
843 participants
Primary outcome timeframe
Up to 7 Months (4 Weeks Postdose 3)
Results posted on
2016-11-16
Participant Flow
The study enrolled healthy participants, 11-17 years old, with 0 lifetime sexual partners, vaccinated against diphtheria, tetanus, pertussis and polio but had not received the vaccine in the past 5 years or any prior human papillomavirus (HPV) vaccine. Additional inclusion and exclusion criteria applied.
Participant milestones
| Measure |
qHPV Vaccine + REPEVAX™ (Concomitant)
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
|
qHPV Vaccine + REPEVAX™ (Non-Concomitant)
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
|
|---|---|---|
|
Overall Study
STARTED
|
419
|
424
|
|
Overall Study
COMPLETED
|
415
|
421
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
| Measure |
qHPV Vaccine + REPEVAX™ (Concomitant)
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
|
qHPV Vaccine + REPEVAX™ (Non-Concomitant)
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Lack of Time
|
1
|
1
|
|
Overall Study
Unwilling to Continue
|
1
|
0
|
|
Overall Study
Anorexia
|
1
|
0
|
Baseline Characteristics
Concomitant Use of Gardasil (V501, Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) With Combined Diptheria, Tetanus, Pertussis and Poliomyelitis Vaccine in Adolescents (V501-024)(COMPLETED)
Baseline characteristics by cohort
| Measure |
qHPV Vaccine + REPEVAX™ (Concomitant)
n=419 Participants
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
|
qHPV Vaccine + REPEVAX™ (Non-Concomitant)
n=424 Participants
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
|
Total
n=843 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
12.1 years
STANDARD_DEVIATION 1.5 • n=5 Participants
|
12.1 years
STANDARD_DEVIATION 1.5 • n=7 Participants
|
12.1 years
STANDARD_DEVIATION 1.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
295 Participants
n=5 Participants
|
288 Participants
n=7 Participants
|
583 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
124 Participants
n=5 Participants
|
136 Participants
n=7 Participants
|
260 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multi-racial
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
413 participants
n=5 Participants
|
415 participants
n=7 Participants
|
828 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 7 Months (4 Weeks Postdose 3)Population: Per-protocol population: participants must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.
Serum antibodies to HPV Type 6 were measured with a Competitive Luminex Immunoassay. Titers were reported in milli Merck Units (mMU)/milliliter (mL). GMTs from participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared GMTs for each HPV type using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction.
Outcome measures
| Measure |
qHPV Vaccine + REPEVAX™ (Concomitant)
n=367 Participants
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
|
qHPV Vaccine + REPEVAX™ (Non-Concomitant)
n=376 Participants
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
|
|---|---|---|
|
Geometric Mean Titers (GMTs) for Anti-HPV 6 at Month 7 (4 Weeks Postdose 3)
|
1151.3 milliMerck units/mL
Interval 1007.5 to 1315.7
|
1244.9 milliMerck units/mL
Interval 1092.4 to 1418.6
|
PRIMARY outcome
Timeframe: Up to 7 Months (4 Weeks Postdose 3)Population: Per-protocol population: participants must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.
Serum antibodies to HPV Type 11 were measured with a Competitive Luminex Immunoassay. Titers were reported in milli Merck Units (mMU)/milliliter (mL). GMTs from participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared GMTs for each HPV type using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction.
Outcome measures
| Measure |
qHPV Vaccine + REPEVAX™ (Concomitant)
n=367 Participants
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
|
qHPV Vaccine + REPEVAX™ (Non-Concomitant)
n=376 Participants
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
|
|---|---|---|
|
Geometric Mean Titers (GMTs) for Anti-HPV 11 at Month 7 (4 Weeks Postdose 3)
|
1338.3 milliMerck units/mL
Interval 1209.0 to 1481.4
|
1460.7 milliMerck units/mL
Interval 1322.4 to 1613.3
|
PRIMARY outcome
Timeframe: Up to 7 Months (4 Weeks Postdose 3)Population: Per-protocol population: participants must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.
Serum antibodies to HPV Type 16 were measured with a Competitive Luminex Immunoassay. Titers were reported in milli Merck Units (mMU)/milliliter (mL). GMTs from participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared GMTs for each HPV type using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction.
Outcome measures
| Measure |
qHPV Vaccine + REPEVAX™ (Concomitant)
n=370 Participants
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
|
qHPV Vaccine + REPEVAX™ (Non-Concomitant)
n=378 Participants
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
|
|---|---|---|
|
Geometric Mean Titers (GMTs) for Anti-HPV 16 at Month 7 (4 Weeks Postdose 3)
|
5835.7 milliMerck units/mL
Interval 5195.7 to 6554.6
|
6508.1 milliMerck units/mL
Interval 5810.3 to 7289.6
|
PRIMARY outcome
Timeframe: Up to 7 Months (4 Weeks Postdose 3)Population: Per-protocol population: participants must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.
Serum antibodies to HPV Type 18 were measured with a Competitive Luminex Immunoassay. Titers were reported in milli Merck Units (mMU)/milliliter (mL). GMTs from participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared GMTs for each HPV type using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction.
Outcome measures
| Measure |
qHPV Vaccine + REPEVAX™ (Concomitant)
n=372 Participants
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
|
qHPV Vaccine + REPEVAX™ (Non-Concomitant)
n=378 Participants
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
|
|---|---|---|
|
Geometric Mean Titers (GMTs) for Anti-HPV 18 at Month 7 (4 Weeks Postdose 3)
|
1096.0 milliMerck units/mL
Interval 958.8 to 1252.8
|
1308.8 milliMerck units/mL
Interval 1148.1 to 1491.9
|
PRIMARY outcome
Timeframe: Up to 7 Months (4 Weeks Postdose 3)Population: Per-protocol population: participants must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.
Seroconversion to HPV Type 6 was defined as changing serostatus from seronegative to seropositive as measured by GMT. The cutoff value for HPV seropositivity was ≥20 mMU/mL. Seroconversion of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) was compared to seroconversion of participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared seroconversion for each HPV type using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine.
Outcome measures
| Measure |
qHPV Vaccine + REPEVAX™ (Concomitant)
n=367 Participants
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
|
qHPV Vaccine + REPEVAX™ (Non-Concomitant)
n=376 Participants
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
|
|---|---|---|
|
Number of Participants Who Seroconverted for HPV Type 6 (HPV 6 ≥20 mMU/mL) by Month 7 (4 Weeks Postdose 3)
|
367 participants
|
375 participants
|
PRIMARY outcome
Timeframe: Up to 7 Months (4 Weeks Postdose 3)Population: Per-protocol population: participants must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.
Seroconversion to HPV Type 11 was defined as changing serostatus from seronegative to seropositive as measured by GMT. The cutoff value for HPV seropositivity was ≥16 mMU/mL. Seroconversion of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) was compared to seroconversion of participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared seroconversion for each HPV type using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine.
Outcome measures
| Measure |
qHPV Vaccine + REPEVAX™ (Concomitant)
n=367 Participants
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
|
qHPV Vaccine + REPEVAX™ (Non-Concomitant)
n=376 Participants
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
|
|---|---|---|
|
Number of Participants Who Seroconverted for HPV Type 11 (HPV 11 ≥16 mMU/mL) by Month 7 (4 Weeks Postdose 3)
|
367 participants
|
376 participants
|
PRIMARY outcome
Timeframe: Up to 7 Months (4 Weeks Postdose 3)Population: Per-protocol population: participants must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.
Seroconversion to HPV Type 16 was defined as changing serostatus from seronegative to seropositive as measured by GMT. The cutoff value for HPV seropositivity was ≥20 mMU/mL. Seroconversion of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) was compared to seroconversion of participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared seroconversion for each HPV type using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine.
Outcome measures
| Measure |
qHPV Vaccine + REPEVAX™ (Concomitant)
n=370 Participants
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
|
qHPV Vaccine + REPEVAX™ (Non-Concomitant)
n=378 Participants
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
|
|---|---|---|
|
Number of Participants Who Seroconverted for HPV Type 16 (HPV 16 ≥20 mMU/mL) by Month 7 (4 Weeks Postdose 3)
|
370 participants
|
378 participants
|
PRIMARY outcome
Timeframe: Up to 7 Months (4 Weeks Postdose 3)Population: Per-protocol population: participants must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.
Seroconversion to HPV Type 18 was defined as changing serostatus from seronegative to seropositive as measured by GMT. The cutoff value for HPV seropositivity was ≥24 mMU/mL. Seroconversion of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) was compared to seroconversion of participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared seroconversion for each HPV type using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine.
Outcome measures
| Measure |
qHPV Vaccine + REPEVAX™ (Concomitant)
n=372 Participants
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
|
qHPV Vaccine + REPEVAX™ (Non-Concomitant)
n=378 Participants
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
|
|---|---|---|
|
Number of Participants Who Seroconverted for HPV Type 18 (HPV 18 ≥24 mMU/mL) by Month 7 (4 Weeks Postdose 3)
|
372 participants
|
378 participants
|
PRIMARY outcome
Timeframe: Up to 1 Month (1 Month Postdose 1)Population: Per-protocol population: participants must have no major protocol violations and must have post-vaccination data.
Diphtheria antitoxin titers were measured using a neutralization assay in Vero cell culture that compares the antitoxin level in the serum of participants with the World Health Organization International Standard for Diphtheria Antitoxin. An acceptable level of response was defined as ≥0.1 International Units (IU)/milliliter (mL). Response levels of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared response levels using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine.
Outcome measures
| Measure |
qHPV Vaccine + REPEVAX™ (Concomitant)
n=380 Participants
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
|
qHPV Vaccine + REPEVAX™ (Non-Concomitant)
n=380 Participants
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
|
|---|---|---|
|
Number of Participants Who Achieved Acceptable Levels of Titers to Diphtheria (Diphtheria ≥0.1 IU/mL) One Month Post-vaccination With REPEVAX™
|
380 participants
|
379 participants
|
PRIMARY outcome
Timeframe: Up to 1 Month (1 Month Postdose 1)Population: Per-protocol population: participants must have no major protocol violations and must have post-vaccination data.
Tetanus antitoxin titers were measured using an indirect, non-competitive enzyme immunoassay (EIA) that compares the antitoxin level in the serum of participants with the World Health Organization International Standard for Tetanus Immunoglobulin. An acceptable level of response was defined as ≥0.1 International Units (IU)/milliliter (mL). Response levels of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared response levels using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine.
Outcome measures
| Measure |
qHPV Vaccine + REPEVAX™ (Concomitant)
n=381 Participants
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
|
qHPV Vaccine + REPEVAX™ (Non-Concomitant)
n=380 Participants
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
|
|---|---|---|
|
Number of Participants Who Achieved Acceptable Levels of Titers to Tetanus (Tetanus ≥0.1 IU/mL) One Month Post-vaccination With REPEVAX™
|
381 participants
|
380 participants
|
PRIMARY outcome
Timeframe: Up to 1 Month (1 Month Postdose 1)Population: Per-protocol population: participants must have no major protocol violations and must have post-vaccination data.
Poliovirus antibody was measured using a poliovirus neutralization assay that assesses the ability of serial dilutions of participant sera to neutralize known amounts of type-specific Sabin poliovirus strains (Types 1, 2, and 3). An acceptable level of response was defined as participants who achieve detectable serum neutralizing antibodies at a ≥1:8 dilution of sera. The response of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) was compared to participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared response levels using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine.
Outcome measures
| Measure |
qHPV Vaccine + REPEVAX™ (Concomitant)
n=367 Participants
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
|
qHPV Vaccine + REPEVAX™ (Non-Concomitant)
n=377 Participants
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
|
|---|---|---|
|
Number of Participants Who Achieved Acceptable Levels of Titers to Poliovirus Type 1 (Poliovirus Type 1 ≥1:8) One Month Postvaccination With REPEVAX™
|
367 participants
|
376 participants
|
PRIMARY outcome
Timeframe: Up to 1 Month (1 Month Postdose 1)Population: Per-protocol population: participants must have no major protocol violations and must have post-vaccination data.
Poliovirus antibody was measured using a poliovirus neutralization assay that assesses the ability of serial dilutions of participant sera to neutralize known amounts of type-specific Sabin poliovirus strains (Types 1, 2, and 3). An acceptable level of response was defined as participants who achieve detectable serum neutralizing antibodies at a ≥1:8 dilution of sera. The response of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) was compared to participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared response levels using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine.
Outcome measures
| Measure |
qHPV Vaccine + REPEVAX™ (Concomitant)
n=369 Participants
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
|
qHPV Vaccine + REPEVAX™ (Non-Concomitant)
n=377 Participants
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
|
|---|---|---|
|
Number of Participants Who Achieved Acceptable Levels of Titers to Poliovirus Type 2 (Poliovirus Type 2 ≥1:8) One Month Postvaccination With REPEVAX™
|
369 participants
|
376 participants
|
PRIMARY outcome
Timeframe: Up to 1 Month (1 Month Postdose 1)Population: Per-protocol population: participants must have no major protocol violations and must have post-vaccination data.
Poliovirus antibody was measured using a poliovirus neutralization assay that assesses the ability of serial dilutions of participant sera to neutralize known amounts of type-specific Sabin poliovirus strains (Types 1, 2, and 3). An acceptable level of response was defined as participants who achieve detectable serum neutralizing antibodies at a ≥1:8 dilution of sera. The response of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) was compared to participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared response levels using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine.
Outcome measures
| Measure |
qHPV Vaccine + REPEVAX™ (Concomitant)
n=361 Participants
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
|
qHPV Vaccine + REPEVAX™ (Non-Concomitant)
n=375 Participants
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
|
|---|---|---|
|
Number of Participants Who Achieved Acceptable Levels of Titers to Poliovirus Type 3 (Poliovirus Type 3 ≥1:8) One Month Postvaccination With REPEVAX™
|
360 participants
|
375 participants
|
PRIMARY outcome
Timeframe: Up to 1 Month (1 Month Postdose 1)Population: Per-protocol population: participants must have no major protocol violations and must have post-vaccination data.
Serum antibodies to Pertussis Toxoid Antibody (anti-PT) were measured with an enzyme-linked immunosorbent assay (ELISA). Titers were reported in ELISA units/mL (ELU/mL) and the lower limit of quantitation for the assay was 5.0 ELU/mL. GMTs from participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared GMTs using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction.
Outcome measures
| Measure |
qHPV Vaccine + REPEVAX™ (Concomitant)
n=381 Participants
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
|
qHPV Vaccine + REPEVAX™ (Non-Concomitant)
n=378 Participants
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
|
|---|---|---|
|
Geometric Mean Titers (GMTs) For Pertussis (Anti-PT) One Month Postvaccination With REPEVAX™
|
38.1 ELISA units/mL
Interval 33.2 to 43.7
|
35.7 ELISA units/mL
Interval 31.1 to 40.9
|
PRIMARY outcome
Timeframe: Up to 1 Month (1 Month Postdose 1)Population: Per-protocol population: participants must have no major protocol violations and must have post-vaccination data.
Serum antibodies to Pertussis Filamentous Haemagglutin Antibody (anti-FHA) were measured with an ELISA. Titers were reported in ELU/mL and the lower limit of quantitation for the assay was 3.0 ELU/mL. GMTs from participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared GMTs using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction.
Outcome measures
| Measure |
qHPV Vaccine + REPEVAX™ (Concomitant)
n=382 Participants
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
|
qHPV Vaccine + REPEVAX™ (Non-Concomitant)
n=381 Participants
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
|
|---|---|---|
|
Geometric Mean Titers (GMTs) For Pertussis (Anti-FHA) One Month Postvaccination With REPEVAX™
|
140.3 ELISA units/mL
Interval 127.5 to 154.4
|
140.7 ELISA units/mL
Interval 127.9 to 154.7
|
PRIMARY outcome
Timeframe: Up to 1 Month (1 Month Postdose 1)Population: Per-protocol population: participants must have no major protocol violations and must have post-vaccination data.
Serum antibodies to Pertussis Pertactin (anti-PRN) were measured with an ELISA. Titers were reported in ELU/mL and the lower limit of quantitation for the assay was 5.0 ELU/mL. GMTs from participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared GMTs using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction.
Outcome measures
| Measure |
qHPV Vaccine + REPEVAX™ (Concomitant)
n=382 Participants
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
|
qHPV Vaccine + REPEVAX™ (Non-Concomitant)
n=381 Participants
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
|
|---|---|---|
|
Geometric Mean Titers (GMTs) For Pertussis (Anti-PRN) One Month Postvaccination With REPEVAX™
|
504.1 ELISA units/mL
Interval 442.7 to 574.0
|
552.8 ELISA units/mL
Interval 485.9 to 629.1
|
PRIMARY outcome
Timeframe: Up to 1 Month (1 Month Postdose 1)Population: Per-protocol population: participants must have no major protocol violations and must have post-vaccination data.
Serum antibodies to Pertussis Fimbrial Agglutinogens Antibody (anti-FIM) were measured with an ELISA. Titers were reported in ELU/mL and the lower limit of quantitation for the assay was 5.0 ELU/mL. GMTs from participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared GMTs for each HPV Type using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction.
Outcome measures
| Measure |
qHPV Vaccine + REPEVAX™ (Concomitant)
n=381 Participants
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
|
qHPV Vaccine + REPEVAX™ (Non-Concomitant)
n=381 Participants
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
|
|---|---|---|
|
Geometric Mean Titers (GMTs) For Pertussis (Anti-FIM) One Month Postvaccination With REPEVAX™
|
561.2 ELISA units/mL
Interval 478.9 to 657.7
|
506.4 ELISA units/mL
Interval 432.5 to 592.8
|
Adverse Events
qHPV Vaccine + REPEVAX™ (Concomitant)
Serious events: 1 serious events
Other events: 405 other events
Deaths: 0 deaths
qHPV Vaccine + REPEVAX™ (Non-Concomitant)
Serious events: 3 serious events
Other events: 406 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
qHPV Vaccine + REPEVAX™ (Concomitant)
n=420 participants at risk
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
|
qHPV Vaccine + REPEVAX™ (Non-Concomitant)
n=423 participants at risk
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/420 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.24%
1/423 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.24%
1/420 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.00%
0/423 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.24%
1/420 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.00%
0/423 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/420 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.24%
1/423 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Musculoskeletal and connective tissue disorders
Ligament disorder
|
0.24%
1/420 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.00%
0/423 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.00%
0/420 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.24%
1/423 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
Other adverse events
| Measure |
qHPV Vaccine + REPEVAX™ (Concomitant)
n=420 participants at risk
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
|
qHPV Vaccine + REPEVAX™ (Non-Concomitant)
n=423 participants at risk
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
|
|---|---|---|
|
Ear and labyrinth disorders
Ear pain
|
0.95%
4/420 • Number of events 4 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.47%
2/423 • Number of events 3 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Gastrointestinal disorders
Abdominal pain
|
4.8%
20/420 • Number of events 26 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
2.8%
12/423 • Number of events 16 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.3%
14/420 • Number of events 15 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
3.8%
16/423 • Number of events 18 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Gastrointestinal disorders
Diarrhoea
|
2.1%
9/420 • Number of events 9 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
4.3%
18/423 • Number of events 21 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Gastrointestinal disorders
Nausea
|
5.0%
21/420 • Number of events 27 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
4.5%
19/423 • Number of events 21 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Gastrointestinal disorders
Vomiting
|
2.6%
11/420 • Number of events 11 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
2.6%
11/423 • Number of events 13 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
General disorders
Fatigue
|
3.1%
13/420 • Number of events 13 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
1.9%
8/423 • Number of events 8 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
General disorders
Malaise
|
1.2%
5/420 • Number of events 5 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.47%
2/423 • Number of events 2 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
General disorders
Pyrexia
|
11.9%
50/420 • Number of events 53 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
13.0%
55/423 • Number of events 60 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
General disorders
Injection site bruising-qHPV
|
1.4%
6/420 • Number of events 6 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
1.2%
5/423 • Number of events 5 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
General disorders
Injection site erythema-qHPV
|
18.3%
77/420 • Number of events 98 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
14.9%
63/423 • Number of events 85 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
General disorders
Injection site haematoma-qHPV
|
1.2%
5/420 • Number of events 5 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
1.7%
7/423 • Number of events 8 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
General disorders
Injection site induration-qHPV
|
0.95%
4/420 • Number of events 4 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
1.2%
5/423 • Number of events 5 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
General disorders
Injection site pain-qHPV
|
79.8%
335/420 • Number of events 641 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
71.9%
304/423 • Number of events 630 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
General disorders
Injection site pruritus-qHPV
|
1.9%
8/420 • Number of events 8 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
2.6%
11/423 • Number of events 11 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
General disorders
Injection site swelling-qHPV
|
21.2%
89/420 • Number of events 131 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
21.3%
90/423 • Number of events 119 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
General disorders
Injection site bruising-Repevax
|
0.95%
4/420 • Number of events 4 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.47%
2/423 • Number of events 2 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
General disorders
Injection site erythema-Repevax
|
18.3%
77/420 • Number of events 77 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
18.7%
79/423 • Number of events 80 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
General disorders
Injection site haematoma-Repevax
|
0.71%
3/420 • Number of events 3 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.95%
4/423 • Number of events 4 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
General disorders
Injection site induration-Repevax
|
0.71%
3/420 • Number of events 3 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.71%
3/423 • Number of events 3 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
General disorders
Injection site irritation-Repevax
|
0.95%
4/420 • Number of events 4 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
1.2%
5/423 • Number of events 5 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
General disorders
Injection site pain-Repevax
|
83.3%
350/420 • Number of events 383 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
81.8%
346/423 • Number of events 373 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
General disorders
Injection site pruritus-Repevax
|
0.95%
4/420 • Number of events 4 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
1.7%
7/423 • Number of events 7 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
General disorders
Injection site swelling-Repevax
|
31.0%
130/420 • Number of events 132 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
31.0%
131/423 • Number of events 132 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
General disorders
Injection site warmth-Repevax
|
0.95%
4/420 • Number of events 4 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.47%
2/423 • Number of events 2 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Infections and infestations
Influenza
|
2.6%
11/420 • Number of events 12 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
2.4%
10/423 • Number of events 13 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Infections and infestations
Nasopharyngitis
|
6.0%
25/420 • Number of events 25 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
6.6%
28/423 • Number of events 29 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Infections and infestations
Pharyngitis
|
1.4%
6/420 • Number of events 6 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.47%
2/423 • Number of events 2 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Infections and infestations
Respiratory tract infection
|
0.48%
2/420 • Number of events 2 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
1.7%
7/423 • Number of events 7 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Infections and infestations
Rhinitis
|
4.5%
19/420 • Number of events 21 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
4.7%
20/423 • Number of events 23 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Infections and infestations
Sinusitis
|
1.4%
6/420 • Number of events 6 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.47%
2/423 • Number of events 2 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Infections and infestations
Upper respiratory tract infection
|
5.0%
21/420 • Number of events 23 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
2.4%
10/423 • Number of events 12 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.4%
6/420 • Number of events 6 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
1.9%
8/423 • Number of events 9 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.2%
5/420 • Number of events 5 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
1.2%
5/423 • Number of events 5 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.71%
3/420 • Number of events 4 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
1.2%
5/423 • Number of events 5 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.9%
8/420 • Number of events 10 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
1.4%
6/423 • Number of events 8 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Nervous system disorders
Dizziness
|
3.3%
14/420 • Number of events 15 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
2.4%
10/423 • Number of events 11 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Nervous system disorders
Headache
|
31.4%
132/420 • Number of events 193 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
26.5%
112/423 • Number of events 168 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.95%
4/420 • Number of events 4 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.71%
3/423 • Number of events 4 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.3%
14/420 • Number of events 15 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
2.6%
11/423 • Number of events 11 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
5.2%
22/420 • Number of events 23 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
5.7%
24/423 • Number of events 29 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.95%
4/420 • Number of events 4 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.24%
1/423 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/420 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.24%
1/423 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Ear and labyrinth disorders
Motion sickness
|
0.48%
2/420 • Number of events 2 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.00%
0/423 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Ear and labyrinth disorders
Vertigo
|
0.48%
2/420 • Number of events 2 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.47%
2/423 • Number of events 2 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.24%
1/420 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.00%
0/423 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/420 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.24%
1/423 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.24%
1/420 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.24%
1/423 • Number of events 2 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/420 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.47%
2/423 • Number of events 2 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Gastrointestinal disorders
Gastritis
|
0.24%
1/420 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.00%
0/423 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Gastrointestinal disorders
Gingivitis
|
0.24%
1/420 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.00%
0/423 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Gastrointestinal disorders
Lip swelling
|
0.24%
1/420 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.00%
0/423 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/420 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.24%
1/423 • Number of events 2 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Gastrointestinal disorders
Teething
|
0.24%
1/420 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.00%
0/423 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Gastrointestinal disorders
Toothache
|
0.48%
2/420 • Number of events 2 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.47%
2/423 • Number of events 2 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Eye disorders
Photophobia
|
0.00%
0/420 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.24%
1/423 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
General disorders
Asthenia
|
0.48%
2/420 • Number of events 2 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.47%
2/423 • Number of events 2 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
General disorders
Axillary pain
|
0.48%
2/420 • Number of events 2 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.47%
2/423 • Number of events 2 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
General disorders
Chills
|
0.71%
3/420 • Number of events 3 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.24%
1/423 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
General disorders
Facial pain
|
0.24%
1/420 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.00%
0/423 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Eye disorders
Conjunctivitis
|
0.24%
1/420 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.24%
1/423 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Eye disorders
Conjunctivitis allergic
|
0.24%
1/420 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.00%
0/423 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Eye disorders
Eye pain
|
0.24%
1/420 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.00%
0/423 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Eye disorders
Eye pruritus
|
0.00%
0/420 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.47%
2/423 • Number of events 2 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/420 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.24%
1/423 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Eye disorders
Ocular discomfort
|
0.00%
0/420 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.24%
1/423 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.24%
1/420 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.00%
0/423 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Blood and lymphatic system disorders
Hypochromasia
|
0.24%
1/420 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.00%
0/423 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.24%
1/420 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.00%
0/423 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.24%
1/420 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.00%
0/423 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
General disorders
Feeling cold
|
0.24%
1/420 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.00%
0/423 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
General disorders
Feeling of body temperature change
|
0.00%
0/420 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.47%
2/423 • Number of events 2 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
General disorders
Influenza like illness
|
0.71%
3/420 • Number of events 3 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.47%
2/423 • Number of events 2 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
General disorders
Local swelling
|
0.00%
0/420 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.24%
1/423 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
General disorders
Vessel puncture site pain
|
0.24%
1/420 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.24%
1/423 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/420 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.47%
2/423 • Number of events 2 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Immune system disorders
Seasonal allergy
|
0.24%
1/420 • Number of events 2 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.00%
0/423 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Infections and infestations
Acute tonsillitis
|
0.24%
1/420 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.00%
0/423 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Infections and infestations
Blister infected
|
0.00%
0/420 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.24%
1/423 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Infections and infestations
Bronchitis
|
0.24%
1/420 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.47%
2/423 • Number of events 2 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Infections and infestations
Cystitis
|
0.24%
1/420 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.24%
1/423 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Infections and infestations
Ear infection
|
0.00%
0/420 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.47%
2/423 • Number of events 2 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Infections and infestations
Gastroenteritis
|
2.4%
10/420 • Number of events 11 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
1.7%
7/423 • Number of events 9 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Infections and infestations
Hordeolum
|
0.24%
1/420 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.00%
0/423 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Infections and infestations
Infection
|
0.00%
0/420 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.24%
1/423 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Infections and infestations
Laryngitis
|
0.00%
0/420 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.24%
1/423 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Infections and infestations
Lice infestation
|
0.00%
0/420 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.24%
1/423 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Infections and infestations
Localised infection
|
0.00%
0/420 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.24%
1/423 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Infections and infestations
Oral herpes
|
0.00%
0/420 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.24%
1/423 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Infections and infestations
Otitis externa
|
0.24%
1/420 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.00%
0/423 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Infections and infestations
Otitis media
|
0.24%
1/420 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.47%
2/423 • Number of events 2 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/420 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.24%
1/423 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Infections and infestations
Sialoadenitis
|
0.24%
1/420 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.00%
0/423 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Infections and infestations
Tinea versicolour
|
0.24%
1/420 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.00%
0/423 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/420 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.71%
3/423 • Number of events 3 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/420 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.24%
1/423 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Infections and infestations
Viral infection
|
0.24%
1/420 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.00%
0/423 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Infections and infestations
Viral tonsillitis
|
0.00%
0/420 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.24%
1/423 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.24%
1/420 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.00%
0/423 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Injury, poisoning and procedural complications
Incision site haemorrhage
|
0.24%
1/420 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.00%
0/423 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.24%
1/420 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.00%
0/423 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/420 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.47%
2/423 • Number of events 2 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.00%
0/420 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.24%
1/423 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Injury, poisoning and procedural complications
Concussion
|
0.24%
1/420 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.47%
2/423 • Number of events 2 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/420 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.47%
2/423 • Number of events 2 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/420 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.47%
2/423 • Number of events 2 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/420 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.24%
1/423 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/420 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.24%
1/423 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.48%
2/420 • Number of events 2 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.24%
1/423 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/420 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.71%
3/423 • Number of events 3 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.00%
0/420 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.24%
1/423 • Number of events 2 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Injury, poisoning and procedural complications
Procedural dizziness
|
0.24%
1/420 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.00%
0/423 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.48%
2/420 • Number of events 3 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.47%
2/423 • Number of events 4 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.24%
1/420 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.00%
0/423 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Injury, poisoning and procedural complications
Wound
|
0.48%
2/420 • Number of events 2 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.00%
0/423 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Investigations
Body temperature increased
|
0.00%
0/420 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.47%
2/423 • Number of events 2 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Investigations
Heart rate increased
|
0.00%
0/420 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.24%
1/423 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Metabolism and nutrition disorders
Anorexia
|
0.24%
1/420 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.47%
2/423 • Number of events 2 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/420 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.24%
1/423 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.24%
1/420 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.00%
0/423 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
0.24%
1/420 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.00%
0/423 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/420 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.24%
1/423 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Musculoskeletal and connective tissue disorders
Growing pains
|
0.24%
1/420 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.00%
0/423 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/420 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.24%
1/423 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.48%
2/420 • Number of events 2 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.24%
1/423 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.24%
1/420 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.47%
2/423 • Number of events 2 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.71%
3/420 • Number of events 3 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.71%
3/423 • Number of events 3 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Musculoskeletal and connective tissue disorders
Sensation of heaviness
|
0.24%
1/420 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.00%
0/423 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.24%
1/420 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.00%
0/423 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.48%
2/420 • Number of events 2 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.00%
0/423 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/420 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.24%
1/423 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Nervous system disorders
Loss of consciousness
|
0.24%
1/420 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.00%
0/423 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Nervous system disorders
Migraine
|
0.00%
0/420 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.71%
3/423 • Number of events 3 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Nervous system disorders
Paraesthesia
|
0.24%
1/420 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.00%
0/423 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Nervous system disorders
Somnolence
|
0.48%
2/420 • Number of events 2 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.00%
0/423 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Nervous system disorders
Syncope
|
0.48%
2/420 • Number of events 2 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.24%
1/423 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Nervous system disorders
Syncope vasovagal
|
0.24%
1/420 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.24%
1/423 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Psychiatric disorders
Eating disorder
|
0.24%
1/420 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.00%
0/423 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/420 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.24%
1/423 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Psychiatric disorders
Listless
|
0.24%
1/420 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.00%
0/423 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Psychiatric disorders
Sleep disorder
|
0.24%
1/420 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.00%
0/423 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Renal and urinary disorders
Dysuria
|
0.24%
1/420 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.00%
0/423 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.24%
1/420 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.00%
0/423 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.00%
0/420 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.24%
1/423 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.71%
3/420 • Number of events 3 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.00%
0/423 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.48%
2/420 • Number of events 2 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.24%
1/423 • Number of events 2 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.48%
2/420 • Number of events 2 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.71%
3/423 • Number of events 3 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.48%
2/420 • Number of events 2 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.24%
1/423 • Number of events 2 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.24%
1/420 • Number of events 2 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.47%
2/423 • Number of events 2 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.24%
1/420 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.00%
0/423 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.24%
1/420 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.00%
0/423 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.48%
2/420 • Number of events 2 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.24%
1/423 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.71%
3/420 • Number of events 3 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.47%
2/423 • Number of events 2 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.24%
1/420 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.00%
0/423 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.71%
3/420 • Number of events 3 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.47%
2/423 • Number of events 2 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.71%
3/420 • Number of events 3 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.47%
2/423 • Number of events 2 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.24%
1/420 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.24%
1/423 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/420 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.24%
1/423 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Skin and subcutaneous tissue disorders
Subcutaneous nodule
|
0.24%
1/420 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.00%
0/423 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
Vascular disorders
Hypotension
|
0.00%
0/420 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.24%
1/423 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
General disorders
Injection site irritation-qHPV
|
0.24%
1/420 • Number of events 2 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.47%
2/423 • Number of events 2 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
General disorders
Injection site warmth-qHPV
|
0.24%
1/420 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.47%
2/423 • Number of events 3 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
General disorders
Injection site anaesthesia-Repevax
|
0.24%
1/420 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.24%
1/423 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
General disorders
Injection site discolouration-qHPV
|
0.24%
1/420 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.24%
1/423 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
General disorders
Injection site discolouration-Repevax
|
0.00%
0/420 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.24%
1/423 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
General disorders
Injection site haemorrhage-qHPV
|
0.71%
3/420 • Number of events 3 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.95%
4/423 • Number of events 4 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
General disorders
Injection site haemorrhage-Repevax
|
0.00%
0/420 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.24%
1/423 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
General disorders
Injection site mass-Repevax
|
0.24%
1/420 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.00%
0/423 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
General disorders
Injection site movement impairment-qHPV
|
0.24%
1/420 • Number of events 2 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.71%
3/423 • Number of events 5 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
General disorders
Injection site movement impairment-Repevax
|
0.71%
3/420 • Number of events 3 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.71%
3/423 • Number of events 3 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
General disorders
Injection site nodule-qHPV
|
0.24%
1/420 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.00%
0/423 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
General disorders
Injection site nodule-Repevax
|
0.24%
1/420 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.00%
0/423 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
General disorders
Injection site papule-Repevax
|
0.00%
0/420 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.24%
1/423 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
General disorders
Injection site rash-Repevax
|
0.24%
1/420 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.00%
0/423 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
General disorders
Injection site reaction-qHPV
|
0.24%
1/420 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.24%
1/423 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
|
General disorders
Injection site reaction-Repevax
|
0.24%
1/420 • Number of events 1 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
0.00%
0/423 • Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER