Trial Outcomes & Findings for Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine in Indian Infants Previously Given a Dose of Hepatitis B Vaccine at Birth (NCT NCT01948193)
NCT ID: NCT01948193
Last Updated: 2015-10-20
Results Overview
Diphtheria antibodies were measured by a toxin neutralization test, tetanus antibodies by an enzyme-linked immunosorbent assay (ELISA), Haemophilus influenzae type b polysaccharide (PRP) antibodies by Farr type radioimmunoassay, poliovirus 1, 2, and 3 antibodies by a neutralization assay, and Hepatitis B (Hep B) antibodies were measured by VITROS ECi/ECiQ Immunodiagnostic System. Description of seroprotection: Diphtheria and Tetanus antibody concentrations ≥0.01 International Units (IU)/mL; Poliovirus 1, 2, and 3 titers ≥8 (1/dilution); Hep B concentrations ≥10 mIU/mL, and PRP ≥0.15 µg/mL.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
177 participants
Primary outcome timeframe
Pre-dose 1 to one month post-dose 3
Results posted on
2015-10-20
Participant Flow
Study participants were enrolled from 19 February 2014 to 30 June 2014 at 2 clinical sites in India.
A total of 177 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and vaccinated.
Participant milestones
| Measure |
All Infants
Infants aged 6 to 8 weeks received 3 injections of Sanofi Pasteur's DTaP IPV HB PRP T combined vaccine at 6, 10 and 14 weeks of age following a documented dose of a commercial oral poliovirus vaccine and recombinant Hepatitis B monovalent vaccine at birth.
|
|---|---|
|
Overall Study
STARTED
|
177
|
|
Overall Study
COMPLETED
|
168
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
All Infants
Infants aged 6 to 8 weeks received 3 injections of Sanofi Pasteur's DTaP IPV HB PRP T combined vaccine at 6, 10 and 14 weeks of age following a documented dose of a commercial oral poliovirus vaccine and recombinant Hepatitis B monovalent vaccine at birth.
|
|---|---|
|
Overall Study
Serious event
|
2
|
|
Overall Study
Lost to Follow-up
|
7
|
Baseline Characteristics
Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine in Indian Infants Previously Given a Dose of Hepatitis B Vaccine at Birth
Baseline characteristics by cohort
| Measure |
All Infants
n=177 Participants
Infants aged 6 to 8 weeks received 3 injections of Sanofi Pasteur's DTaP-IPV-HB-PRP-T combined vaccine at 6, 10 and 14 weeks of age following a documented dose of a commercial oral poliovirus vaccine and recombinant Hepatitis B monovalent vaccine at birth.
|
|---|---|
|
Age, Categorical
<=18 years
|
177 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
6.9 Weeks
STANDARD_DEVIATION 0.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
78 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
99 Participants
n=5 Participants
|
|
Region of Enrollment
India
|
177 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-dose 1 to one month post-dose 3Population: Seroprotection was assessed in the Per-protocol Analysis Set.
Diphtheria antibodies were measured by a toxin neutralization test, tetanus antibodies by an enzyme-linked immunosorbent assay (ELISA), Haemophilus influenzae type b polysaccharide (PRP) antibodies by Farr type radioimmunoassay, poliovirus 1, 2, and 3 antibodies by a neutralization assay, and Hepatitis B (Hep B) antibodies were measured by VITROS ECi/ECiQ Immunodiagnostic System. Description of seroprotection: Diphtheria and Tetanus antibody concentrations ≥0.01 International Units (IU)/mL; Poliovirus 1, 2, and 3 titers ≥8 (1/dilution); Hep B concentrations ≥10 mIU/mL, and PRP ≥0.15 µg/mL.
Outcome measures
| Measure |
All Infants
n=156 Participants
Infants aged 6 to 8 weeks received 3 injections of Sanofi Pasteur's DTaP-IPV-HB-PRP-T combined vaccine at 6, 10 and 14 weeks of age following a documented dose of a commercial oral poliovirus vaccine and recombinant Hepatitis B monovalent vaccine at birth.
|
|---|---|
|
Percentage of Participants With Seroprotection After Vaccinations With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of a Commercial Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth
Anti-Diphtheria; Post-dose 3; ≥0.01, (N=135)
|
99.3 Percentage of participants
|
|
Percentage of Participants With Seroprotection After Vaccinations With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of a Commercial Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth
Anti-Tetanus; Post-dose 3, ≥0.01 (N=134)
|
100 Percentage of participants
|
|
Percentage of Participants With Seroprotection After Vaccinations With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of a Commercial Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth
Anti-Polio 1; Post-dose 3 (N=145)
|
100 Percentage of participants
|
|
Percentage of Participants With Seroprotection After Vaccinations With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of a Commercial Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth
Anti-Polio 2; Post-dose 3 (N=146)
|
100 Percentage of participants
|
|
Percentage of Participants With Seroprotection After Vaccinations With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of a Commercial Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth
Anti-Polio 3; Post-dose 3 (N=144)
|
100 Percentage of participants
|
|
Percentage of Participants With Seroprotection After Vaccinations With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of a Commercial Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth
Anti-Hep B; Post-dose 3, ≥10 (N=152)
|
100 Percentage of participants
|
|
Percentage of Participants With Seroprotection After Vaccinations With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of a Commercial Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth
Anti-PRP; Post-dose 3, ≥0.15 (N=156)
|
100 Percentage of participants
|
PRIMARY outcome
Timeframe: Pre-dose 1 to one month post-dose 3Population: Vaccine response was assessed in the Per-protocol Analysis Set.
Anti-pertussis toxin (PT) and anti-filamentous hemagglutinin (FHA) antibodies were measured with an ELISA. Vaccine response was defined as percentage of participants with post-dose 3 anti-PT and anti-FHA antibody concentrations in ELISA units (EU)/mL ≥ 4 x Lower Limit of Quantification (LLOQ) if pre-vaccination concentration was \< 4 x LLOQ or ≥ pre-vaccination concentration if pre-vaccination concentrations ≥ 4 x LLOQ.
Outcome measures
| Measure |
All Infants
n=156 Participants
Infants aged 6 to 8 weeks received 3 injections of Sanofi Pasteur's DTaP-IPV-HB-PRP-T combined vaccine at 6, 10 and 14 weeks of age following a documented dose of a commercial oral poliovirus vaccine and recombinant Hepatitis B monovalent vaccine at birth.
|
|---|---|
|
Percentage of Participants With Vaccine Response After Vaccinations With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of a Commercial Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth
Anti-PT; Pre-dose 1 (N=147)
|
59.9 Percentage of participants
|
|
Percentage of Participants With Vaccine Response After Vaccinations With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of a Commercial Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth
Anti-PT; Vaccine response (N=146)
|
93.8 Percentage of participants
|
|
Percentage of Participants With Vaccine Response After Vaccinations With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of a Commercial Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth
Anti-PT; ≥4-fold increase (N=146)
|
88.4 Percentage of participants
|
|
Percentage of Participants With Vaccine Response After Vaccinations With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of a Commercial Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth
Anti-FHA; Pre-dose 1 (N=151)
|
88.7 Percentage of participants
|
|
Percentage of Participants With Vaccine Response After Vaccinations With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of a Commercial Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth
Anti-FHA; Vaccine response (N=147)
|
99.3 Percentage of participants
|
|
Percentage of Participants With Vaccine Response After Vaccinations With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of a Commercial Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth
Anti-FHA; ≥4-fold increase (N=147)
|
90.5 Percentage of participants
|
SECONDARY outcome
Timeframe: Pre-dose 1 to one month post-dose 3Population: Seroprotection was assessed in the Per-protocol Analysis Set.
Diphtheria antibodies were measured by a toxin neutralization test, tetanus antibodies by an enzyme-linked immunosorbent assay (ELISA), Haemophilus influenzae type b polysaccharide (PRP) antibodies by Farr type radioimmunoassay, poliovirus 1, 2, and 3 antibodies by a neutralization assay, and Hepatitis B (Hep B) antibodies were measured by VITROS ECi/ECiQ Immunodiagnostic System. Description of seroprotection: Diphtheria and Tetanus antibody concentrations ≥0.01 International Units (IU)/mL; Poliovirus 1, 2, and 3 titers ≥8 (1/dilution); Hep B concentrations ≥10 mIU/mL, and PRP ≥0.15 µg/mL.
Outcome measures
| Measure |
All Infants
n=156 Participants
Infants aged 6 to 8 weeks received 3 injections of Sanofi Pasteur's DTaP-IPV-HB-PRP-T combined vaccine at 6, 10 and 14 weeks of age following a documented dose of a commercial oral poliovirus vaccine and recombinant Hepatitis B monovalent vaccine at birth.
|
|---|---|
|
Percentage of Participants With Seroprotection Before and After Vaccinations With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of a Commercial Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth
Anti-Diphtheria; Pre-dose, 1 ≥0.01 (N=152)
|
67.1 Percentage of participants
|
|
Percentage of Participants With Seroprotection Before and After Vaccinations With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of a Commercial Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth
Anti-Diphtheria; Pre-dose 1, ≥0.1 (N=152)
|
15.8 Percentage of participants
|
|
Percentage of Participants With Seroprotection Before and After Vaccinations With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of a Commercial Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth
Anti-Diphtheria; Post-dose 3; ≥0.01, (N=135)
|
99.3 Percentage of participants
|
|
Percentage of Participants With Seroprotection Before and After Vaccinations With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of a Commercial Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth
Anti-Diphtheria; Post-dose 3; ≥0.1 (N=135)
|
49.6 Percentage of participants
|
|
Percentage of Participants With Seroprotection Before and After Vaccinations With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of a Commercial Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth
Anti-Diphtheria; Post-dose 3, ≥1.0 (N=135)
|
5.2 Percentage of participants
|
|
Percentage of Participants With Seroprotection Before and After Vaccinations With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of a Commercial Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth
Anti-Tetanus; Post-dose 3, ≥0.01 (N=134)
|
100.0 Percentage of participants
|
|
Percentage of Participants With Seroprotection Before and After Vaccinations With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of a Commercial Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth
Anti-Tetanus; Post-dose 3, ≥0.1 (N=134)
|
100.0 Percentage of participants
|
|
Percentage of Participants With Seroprotection Before and After Vaccinations With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of a Commercial Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth
Anti-Tetanus; Post-dose 3, ≥1.0 (N=134)
|
84.3 Percentage of participants
|
|
Percentage of Participants With Seroprotection Before and After Vaccinations With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of a Commercial Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth
Anti-Polio 1; Post-dose 3 (N=145)
|
100.0 Percentage of participants
|
|
Percentage of Participants With Seroprotection Before and After Vaccinations With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of a Commercial Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth
Anti-Polio 2; Post-dose 3 (N=146)
|
100.0 Percentage of participants
|
|
Percentage of Participants With Seroprotection Before and After Vaccinations With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of a Commercial Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth
Anti-Polio 3; Post-dose 3 (N=144)
|
100.0 Percentage of participants
|
|
Percentage of Participants With Seroprotection Before and After Vaccinations With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of a Commercial Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth
Anti-Hep B; Pre-dose 1, ≥10 (N=152)
|
13.2 Percentage of participants
|
|
Percentage of Participants With Seroprotection Before and After Vaccinations With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of a Commercial Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth
Anti-Hep B; Post-dose 3, ≥10 (N=152)
|
100.0 Percentage of participants
|
|
Percentage of Participants With Seroprotection Before and After Vaccinations With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of a Commercial Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth
Anti-Hep B; Post-dose 3, ≥100 (N=152)
|
99.3 Percentage of participants
|
|
Percentage of Participants With Seroprotection Before and After Vaccinations With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of a Commercial Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth
Anti-PRP; Post-dose 3, ≥0.15 (N=156)
|
100.0 Percentage of participants
|
|
Percentage of Participants With Seroprotection Before and After Vaccinations With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of a Commercial Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth
Anti-PRP; Post-dose 3, ≥1.0 (N=156)
|
93.6 Percentage of participants
|
SECONDARY outcome
Timeframe: Pre-dose 1 to one month post-dose 3Population: Geometric mean titers were assessed in the Per-protocol Analysis Set.
Diphtheria antibodies were measured by a toxin neutralization test, tetanus, PT, and FHA antibodies by an ELISA, PRP antibodies by a Farr type radioimmunoassay, poliovirus 1, 2, and 3 antibodies by a neutralization assay, and Hep B antibodies were measured by VITROS ECi/ECiQ Immunodiagnostic System.
Outcome measures
| Measure |
All Infants
n=156 Participants
Infants aged 6 to 8 weeks received 3 injections of Sanofi Pasteur's DTaP-IPV-HB-PRP-T combined vaccine at 6, 10 and 14 weeks of age following a documented dose of a commercial oral poliovirus vaccine and recombinant Hepatitis B monovalent vaccine at birth.
|
|---|---|
|
Geometric Mean Titers of Antibodies Against Vaccine Antigens After Vaccinations With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine After a Documented Dose of an Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth
Anti-Diphtheria; Pre-dose 1 (N=152)
|
0.019 Titers
Interval 0.015 to 0.025
|
|
Geometric Mean Titers of Antibodies Against Vaccine Antigens After Vaccinations With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine After a Documented Dose of an Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth
Anti-Diphtheria; Post-dose 3 (N=135)
|
0.120 Titers
Interval 0.099 to 0.146
|
|
Geometric Mean Titers of Antibodies Against Vaccine Antigens After Vaccinations With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine After a Documented Dose of an Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth
Anti-Tetanus; Post-dose 3 (N=134)
|
1.95 Titers
Interval 1.75 to 2.17
|
|
Geometric Mean Titers of Antibodies Against Vaccine Antigens After Vaccinations With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine After a Documented Dose of an Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth
Anti-PT; Pre-dose 1 (N=147)
|
3.84 Titers
Interval 3.0 to 4.91
|
|
Geometric Mean Titers of Antibodies Against Vaccine Antigens After Vaccinations With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine After a Documented Dose of an Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth
Anti-PT; Post-dose 3 (N=155)
|
191 Titers
Interval 173.0 to 210.0
|
|
Geometric Mean Titers of Antibodies Against Vaccine Antigens After Vaccinations With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine After a Documented Dose of an Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth
Anti-FHA; Pre-dose 1 (N=151)
|
6.17 Titers
Interval 5.1 to 7.48
|
|
Geometric Mean Titers of Antibodies Against Vaccine Antigens After Vaccinations With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine After a Documented Dose of an Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth
Anti-FHA; Post-dose 3 (N=152)
|
226 Titers
Interval 208.0 to 247.0
|
|
Geometric Mean Titers of Antibodies Against Vaccine Antigens After Vaccinations With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine After a Documented Dose of an Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth
Anti-Polio 1; Post-dose 3 (N=145)
|
1124 Titers
Interval 861.0 to 1468.0
|
|
Geometric Mean Titers of Antibodies Against Vaccine Antigens After Vaccinations With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine After a Documented Dose of an Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth
Anti-Polio 2; Post-dose 3 (N=146)
|
1401 Titers
Interval 1108.0 to 1771.0
|
|
Geometric Mean Titers of Antibodies Against Vaccine Antigens After Vaccinations With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine After a Documented Dose of an Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth
Anti-Polio 3; Post-dose 3 (N=144)
|
2019 Titers
Interval 1672.0 to 2437.0
|
|
Geometric Mean Titers of Antibodies Against Vaccine Antigens After Vaccinations With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine After a Documented Dose of an Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth
Anti-Hep B; Pre-dose 1 (N=152)
|
3.78 Titers
Interval 3.23 to 4.43
|
|
Geometric Mean Titers of Antibodies Against Vaccine Antigens After Vaccinations With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine After a Documented Dose of an Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth
Anti-Hep B; Post-dose 3 (N=152)
|
2491 Titers
Interval 2073.0 to 2995.0
|
|
Geometric Mean Titers of Antibodies Against Vaccine Antigens After Vaccinations With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine After a Documented Dose of an Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth
Anti-PRP; Post-dose 3 (N=156)
|
7.86 Titers
Interval 6.35 to 9.73
|
SECONDARY outcome
Timeframe: Pre-dose 1 to one month post-dose 3Population: Geometric mean titer ratios were assessed in the Per-protocol Analysis Set.
Diphtheria antibodies were measured by a toxin neutralization test, PT and FHA antibodies by an ELISA, and Hep B antibodies were measured by VITROS ECi/ECiQ Immunodiagnostic System.
Outcome measures
| Measure |
All Infants
n=156 Participants
Infants aged 6 to 8 weeks received 3 injections of Sanofi Pasteur's DTaP-IPV-HB-PRP-T combined vaccine at 6, 10 and 14 weeks of age following a documented dose of a commercial oral poliovirus vaccine and recombinant Hepatitis B monovalent vaccine at birth.
|
|---|---|
|
Geometric Mean Titer Ratios of Antibodies Against Vaccine Antigens After Vaccinations With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine After a Documented Dose of Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth
Anti-FHA (N=147)
|
36.6 Titer ratio
Interval 28.6 to 46.8
|
|
Geometric Mean Titer Ratios of Antibodies Against Vaccine Antigens After Vaccinations With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine After a Documented Dose of Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth
Anti-Diphtheria (N=131)
|
5.85 Titer ratio
Interval 3.93 to 8.72
|
|
Geometric Mean Titer Ratios of Antibodies Against Vaccine Antigens After Vaccinations With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine After a Documented Dose of Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth
Anti-PT (N=146)
|
50.7 Titer ratio
Interval 37.3 to 69.0
|
|
Geometric Mean Titer Ratios of Antibodies Against Vaccine Antigens After Vaccinations With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine After a Documented Dose of Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth
Anti-Hep B (N=149)
|
686 Titer ratio
Interval 542.0 to 870.0
|
SECONDARY outcome
Timeframe: Within 7 days after each vaccine injectionPopulation: Solicited injection-site and systemic reactions were assessed in the Safety Analysis Set.
Injection-site reactions: Tenderness, Erythema, and Swelling. Systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3 Injection site reactions: Tenderness, Cries when injected limb is moved, or reduced movement of injected limb; Erythema and Swelling, ≥50 mm. Grade 3 Systemic reactions: Fever, \>39.5°C or \>103.1°F; Vomiting, ≥6 episodes/24 hours or requires parenteral hydration; Crying abnormal, \>3 hours; Drowsiness, Sleeping most of the time/difficult to wake up; Appetite lost, Refuses ≥3 or most feeds/meals; Irritability, Inconsolable.
Outcome measures
| Measure |
All Infants
n=177 Participants
Infants aged 6 to 8 weeks received 3 injections of Sanofi Pasteur's DTaP-IPV-HB-PRP-T combined vaccine at 6, 10 and 14 weeks of age following a documented dose of a commercial oral poliovirus vaccine and recombinant Hepatitis B monovalent vaccine at birth.
|
|---|---|
|
Percentage of Participants Reporting Solicited Injection-site or Systemic Reaction After Each Vaccination With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of Oral Poliovirus and Recombinant Hep B Vaccine at Birth
Any Injection-site Tenderness; Post Inj. 1 (N=174)
|
19.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site or Systemic Reaction After Each Vaccination With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of Oral Poliovirus and Recombinant Hep B Vaccine at Birth
Grade 3 Inj. site Tenderness; Post Inj 1 (N=174)
|
2.3 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site or Systemic Reaction After Each Vaccination With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of Oral Poliovirus and Recombinant Hep B Vaccine at Birth
Any Injection-site Erythema; Post Inj. 1 (N=174)
|
4.6 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site or Systemic Reaction After Each Vaccination With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of Oral Poliovirus and Recombinant Hep B Vaccine at Birth
Grade 3 Inj. site Erythema; Post Inj. 1 (N=174)
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site or Systemic Reaction After Each Vaccination With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of Oral Poliovirus and Recombinant Hep B Vaccine at Birth
Any Injection-site Swelling; Post Inj. 1 (N=174)
|
10.3 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site or Systemic Reaction After Each Vaccination With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of Oral Poliovirus and Recombinant Hep B Vaccine at Birth
Grade 3 Inj. site Swelling; Post Inj. 1 (N=174)
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site or Systemic Reaction After Each Vaccination With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of Oral Poliovirus and Recombinant Hep B Vaccine at Birth
Any Injection-site Tenderness; Post Inj. 2 (N=174)
|
13.8 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site or Systemic Reaction After Each Vaccination With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of Oral Poliovirus and Recombinant Hep B Vaccine at Birth
Grade 3 Inj.-site Tenderness; Post Inj. 2 (N=174)
|
1.1 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site or Systemic Reaction After Each Vaccination With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of Oral Poliovirus and Recombinant Hep B Vaccine at Birth
Any Injection-site Erythema; Post Inj. 2 (N=174)
|
3.4 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site or Systemic Reaction After Each Vaccination With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of Oral Poliovirus and Recombinant Hep B Vaccine at Birth
Grade 3 Inj. site Erythema; Post Inj. 2 (N=174)
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site or Systemic Reaction After Each Vaccination With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of Oral Poliovirus and Recombinant Hep B Vaccine at Birth
Any Injection-site Swelling; Post Inj. 2 (N=174)
|
3.4 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site or Systemic Reaction After Each Vaccination With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of Oral Poliovirus and Recombinant Hep B Vaccine at Birth
Grade 3 Inj. site Swelling; Post Inj. 2 (N=174)
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site or Systemic Reaction After Each Vaccination With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of Oral Poliovirus and Recombinant Hep B Vaccine at Birth
Any Injection-site Tenderness; Post Inj. 3 (N=168)
|
11.9 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site or Systemic Reaction After Each Vaccination With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of Oral Poliovirus and Recombinant Hep B Vaccine at Birth
Grade 3 Inj. site Tenderness; Post Inj. 3 (N=168)
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site or Systemic Reaction After Each Vaccination With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of Oral Poliovirus and Recombinant Hep B Vaccine at Birth
Any Injection-site Erythema; Post Inj. 3 (N=168)
|
0.6 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site or Systemic Reaction After Each Vaccination With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of Oral Poliovirus and Recombinant Hep B Vaccine at Birth
Grade 3 Inj. site Erythema; Post Inj. 3 (N=168)
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site or Systemic Reaction After Each Vaccination With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of Oral Poliovirus and Recombinant Hep B Vaccine at Birth
Any Injection-site Swelling; Post Inj. 3 (N=168)
|
6.5 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site or Systemic Reaction After Each Vaccination With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of Oral Poliovirus and Recombinant Hep B Vaccine at Birth
Grade 3 Inj. site Swelling; Post Inj. 3 (N=168)
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site or Systemic Reaction After Each Vaccination With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of Oral Poliovirus and Recombinant Hep B Vaccine at Birth
Any Fever; Post-injection 1 (N=174)
|
7.5 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site or Systemic Reaction After Each Vaccination With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of Oral Poliovirus and Recombinant Hep B Vaccine at Birth
Grade 3 Fever; Post-injection 1 (N=174)
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site or Systemic Reaction After Each Vaccination With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of Oral Poliovirus and Recombinant Hep B Vaccine at Birth
Any Vomiting; Post-injection 1 (N=174)
|
9.8 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site or Systemic Reaction After Each Vaccination With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of Oral Poliovirus and Recombinant Hep B Vaccine at Birth
Grade 3 Vomiting; Post-injection 1 (N=174)
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site or Systemic Reaction After Each Vaccination With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of Oral Poliovirus and Recombinant Hep B Vaccine at Birth
Any Crying abnormal; Post-injection 1 (N=174)
|
16.1 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site or Systemic Reaction After Each Vaccination With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of Oral Poliovirus and Recombinant Hep B Vaccine at Birth
Grade 3 Crying abnormal; Post-injection 1 (N=174)
|
1.1 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site or Systemic Reaction After Each Vaccination With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of Oral Poliovirus and Recombinant Hep B Vaccine at Birth
Any Drowsiness; Post injection 1 (N=174)
|
9.8 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site or Systemic Reaction After Each Vaccination With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of Oral Poliovirus and Recombinant Hep B Vaccine at Birth
Grade 3 Drowsiness; Post Inj. 1 (N=174)
|
1.1 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site or Systemic Reaction After Each Vaccination With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of Oral Poliovirus and Recombinant Hep B Vaccine at Birth
Any Appetite lost; Post Inj. 1 (N=174)
|
6.9 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site or Systemic Reaction After Each Vaccination With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of Oral Poliovirus and Recombinant Hep B Vaccine at Birth
Grade 3 Appetite lost; Post Inj. 1 (N=174)
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site or Systemic Reaction After Each Vaccination With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of Oral Poliovirus and Recombinant Hep B Vaccine at Birth
Any Irritability; Post Inj. 1 (N=174)
|
22.4 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site or Systemic Reaction After Each Vaccination With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of Oral Poliovirus and Recombinant Hep B Vaccine at Birth
Grade 3 Irritability; Post Inj. 1 (N=174)
|
0.6 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site or Systemic Reaction After Each Vaccination With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of Oral Poliovirus and Recombinant Hep B Vaccine at Birth
Any Fever; Post Inj. 2 (N=174)
|
8.6 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site or Systemic Reaction After Each Vaccination With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of Oral Poliovirus and Recombinant Hep B Vaccine at Birth
Grade 3 Fever; Post Inj. 2 (N=174)
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site or Systemic Reaction After Each Vaccination With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of Oral Poliovirus and Recombinant Hep B Vaccine at Birth
Any Vomiting; Post Inj. 2 (N=174)
|
3.4 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site or Systemic Reaction After Each Vaccination With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of Oral Poliovirus and Recombinant Hep B Vaccine at Birth
Grade 3 Vomiting; Post Inj. 2 (N=174)
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site or Systemic Reaction After Each Vaccination With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of Oral Poliovirus and Recombinant Hep B Vaccine at Birth
Any Crying abnormal; Post Inj. 2 (N=174)
|
9.8 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site or Systemic Reaction After Each Vaccination With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of Oral Poliovirus and Recombinant Hep B Vaccine at Birth
Grade 3 Crying abnormal; Post Inj. 2 (N=174)
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site or Systemic Reaction After Each Vaccination With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of Oral Poliovirus and Recombinant Hep B Vaccine at Birth
Any Drowsiness; Post Inj. 2 (N=174)
|
3.4 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site or Systemic Reaction After Each Vaccination With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of Oral Poliovirus and Recombinant Hep B Vaccine at Birth
Grade 3 Drowsiness; Post Inj. 2 (N=174)
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site or Systemic Reaction After Each Vaccination With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of Oral Poliovirus and Recombinant Hep B Vaccine at Birth
Any Appetite lost; Post Inj. 2 (N=174)
|
3.4 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site or Systemic Reaction After Each Vaccination With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of Oral Poliovirus and Recombinant Hep B Vaccine at Birth
Grade 3 Appetite lost; Post Inj. 2 (N=174)
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site or Systemic Reaction After Each Vaccination With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of Oral Poliovirus and Recombinant Hep B Vaccine at Birth
Any Irritability; Post Inj. 2 (N=174)
|
16.7 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site or Systemic Reaction After Each Vaccination With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of Oral Poliovirus and Recombinant Hep B Vaccine at Birth
Grade 3 Irritability; Post Inj. 2 (N=174)
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site or Systemic Reaction After Each Vaccination With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of Oral Poliovirus and Recombinant Hep B Vaccine at Birth
Any Fever; Post Inj. 3 (N=168)
|
7.1 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site or Systemic Reaction After Each Vaccination With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of Oral Poliovirus and Recombinant Hep B Vaccine at Birth
Grade 3 Fever; Post Inj. 3 (N=168)
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site or Systemic Reaction After Each Vaccination With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of Oral Poliovirus and Recombinant Hep B Vaccine at Birth
Any Vomiting; Post Inj. 3 (N=168)
|
3.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site or Systemic Reaction After Each Vaccination With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of Oral Poliovirus and Recombinant Hep B Vaccine at Birth
Grade 3 Vomiting; Post Inj. 3 (N=168)
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site or Systemic Reaction After Each Vaccination With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of Oral Poliovirus and Recombinant Hep B Vaccine at Birth
Any Crying abnormal; Post Inj. 3 (N=168)
|
7.7 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site or Systemic Reaction After Each Vaccination With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of Oral Poliovirus and Recombinant Hep B Vaccine at Birth
Grade 3 Crying abnormal; Post Inj. 3 (N=168)
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site or Systemic Reaction After Each Vaccination With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of Oral Poliovirus and Recombinant Hep B Vaccine at Birth
Any Drowsiness; Post Inj. 3 (N=168)
|
3.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site or Systemic Reaction After Each Vaccination With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of Oral Poliovirus and Recombinant Hep B Vaccine at Birth
Grade 3 Drowsiness; Post Inj. 3 (N=168)
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site or Systemic Reaction After Each Vaccination With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of Oral Poliovirus and Recombinant Hep B Vaccine at Birth
Any Appetite lost; Post Inj. 3 (N=168)
|
3.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site or Systemic Reaction After Each Vaccination With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of Oral Poliovirus and Recombinant Hep B Vaccine at Birth
Grade 3 Appetite lost; Post Inj. 3 (N=168)
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site or Systemic Reaction After Each Vaccination With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of Oral Poliovirus and Recombinant Hep B Vaccine at Birth
Any Irritability; Post Inj. 3 (N=168)
|
12.5 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site or Systemic Reaction After Each Vaccination With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of Oral Poliovirus and Recombinant Hep B Vaccine at Birth
Grade 3 Irritability; Post Inj. 3 (N=168)
|
0.0 Percentage of participants
|
Adverse Events
All Infants
Serious events: 3 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All Infants
n=177 participants at risk
Infants aged 6 to 8 weeks received 3 injections of Sanofi Pasteur's DTaP IPV HB PRP T combined vaccine at 6, 10 and 14 weeks of age following a documented dose of a commercial oral poliovirus vaccine and recombinant Hepatitis B monovalent vaccine at birth.
|
|---|---|
|
General disorders
Death unexplained
|
0.56%
1/177 • Number of events 1 • Adverse event data were collected following first vaccination up to Day 30 post-dose 3.
|
|
Infections and infestations
Bronchopneumonia
|
0.56%
1/177 • Number of events 1 • Adverse event data were collected following first vaccination up to Day 30 post-dose 3.
|
|
Infections and infestations
Septic shock
|
0.56%
1/177 • Number of events 1 • Adverse event data were collected following first vaccination up to Day 30 post-dose 3.
|
|
Nervous system disorders
Epilepsy
|
0.56%
1/177 • Number of events 1 • Adverse event data were collected following first vaccination up to Day 30 post-dose 3.
|
Other adverse events
| Measure |
All Infants
n=177 participants at risk
Infants aged 6 to 8 weeks received 3 injections of Sanofi Pasteur's DTaP IPV HB PRP T combined vaccine at 6, 10 and 14 weeks of age following a documented dose of a commercial oral poliovirus vaccine and recombinant Hepatitis B monovalent vaccine at birth.
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
5.1%
9/177 • Number of events 9 • Adverse event data were collected following first vaccination up to Day 30 post-dose 3.
|
|
Infections and infestations
Upper respiratory tract infection
|
11.9%
21/177 • Number of events 24 • Adverse event data were collected following first vaccination up to Day 30 post-dose 3.
|
|
General disorders
Injection site Tenderness
|
19.0%
33/174 • Number of events 33 • Adverse event data were collected following first vaccination up to Day 30 post-dose 3.
|
|
General disorders
Injection site Erythema
|
4.6%
8/174 • Number of events 8 • Adverse event data were collected following first vaccination up to Day 30 post-dose 3.
|
|
General disorders
Injection site Swelling
|
10.3%
18/174 • Number of events 18 • Adverse event data were collected following first vaccination up to Day 30 post-dose 3.
|
|
General disorders
Fever
|
8.6%
15/174 • Number of events 15 • Adverse event data were collected following first vaccination up to Day 30 post-dose 3.
|
|
Gastrointestinal disorders
Vomiting
|
9.8%
17/174 • Number of events 17 • Adverse event data were collected following first vaccination up to Day 30 post-dose 3.
|
|
Psychiatric disorders
Crying abnormal
|
16.1%
28/174 • Number of events 28 • Adverse event data were collected following first vaccination up to Day 30 post-dose 3.
|
|
Nervous system disorders
Drowsiness
|
9.8%
17/174 • Number of events 17 • Adverse event data were collected following first vaccination up to Day 30 post-dose 3.
|
|
Metabolism and nutrition disorders
Appetite lost
|
6.9%
12/174 • Number of events 12 • Adverse event data were collected following first vaccination up to Day 30 post-dose 3.
|
|
Psychiatric disorders
Irritability
|
22.4%
39/174 • Number of events 39 • Adverse event data were collected following first vaccination up to Day 30 post-dose 3.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications
- Publication restrictions are in place
Restriction type: OTHER