Trial Outcomes & Findings for Safety of DTPa-IPV/Hib & DTPa-HBV-IPV/Hib, Followed by DTPa-IPV/Hib Vaccine in Infants Who Received Hepatitis B Vaccine (NCT NCT00325143)
NCT ID: NCT00325143
Last Updated: 2018-06-06
Results Overview
Assessed solicited local and general symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
702 participants
Primary outcome timeframe
During the 4-day (Days 0-3) post-vaccination period following each dose and across doses
Results posted on
2018-06-06
Participant Flow
During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
Participant milestones
| Measure |
Infanrix Hexa Group
Healthy male or female subjects between and including 11 to 17 weeks of age, who were previously vaccinated with Rotarix in study 444563/028, additionally received 2 doses of Infanrix-IPV/Hib vaccine (at 3 and 4 months of age), 2 doses of Rotarix vaccine (at 2 and 4 months of age) and one dose of Infanrix Hexa vaccine (at 5 months of age) as a primary vaccination course, followed by administration of a booster dose of Infanrix-IPV/Hib vaccine (at 18 months of age). The Infanrix-IPV/Hib and Infanrix Hexa vaccines were administered intramuscularly into the right antero-lateral thigh, while the Rotarix vaccine was given orally.
|
|---|---|
|
Overall Study
STARTED
|
702
|
|
Overall Study
COMPLETED
|
676
|
|
Overall Study
NOT COMPLETED
|
26
|
Reasons for withdrawal
| Measure |
Infanrix Hexa Group
Healthy male or female subjects between and including 11 to 17 weeks of age, who were previously vaccinated with Rotarix in study 444563/028, additionally received 2 doses of Infanrix-IPV/Hib vaccine (at 3 and 4 months of age), 2 doses of Rotarix vaccine (at 2 and 4 months of age) and one dose of Infanrix Hexa vaccine (at 5 months of age) as a primary vaccination course, followed by administration of a booster dose of Infanrix-IPV/Hib vaccine (at 18 months of age). The Infanrix-IPV/Hib and Infanrix Hexa vaccines were administered intramuscularly into the right antero-lateral thigh, while the Rotarix vaccine was given orally.
|
|---|---|
|
Overall Study
Lost to follow-up(complete vacc. course)
|
13
|
|
Overall Study
Migrated/moved from study area
|
1
|
|
Overall Study
Lost to follow-up(incompl. vacc. course)
|
4
|
|
Overall Study
Withdrawal by Subject
|
8
|
Baseline Characteristics
Safety of DTPa-IPV/Hib & DTPa-HBV-IPV/Hib, Followed by DTPa-IPV/Hib Vaccine in Infants Who Received Hepatitis B Vaccine
Baseline characteristics by cohort
| Measure |
Infanrix Hexa Group
n=702 Participants
Healthy male or female subjects between and including 11 to 17 weeks of age, who were previously vaccinated with Rotarix in study 444563/028, additionally received 2 doses of Infanrix-IPV/Hib vaccine (at 3 and 4 months of age), 2 doses of Rotarix vaccine (at 2 and 4 months of age) and one dose of Infanrix Hexa vaccine (at 5 months of age) as a primary vaccination course, followed by administration of a booster dose of Infanrix-IPV/Hib vaccine (at 18 months of age). The Infanrix-IPV/Hib and Infanrix Hexa vaccines were administered intramuscularly into the right antero-lateral thigh, while the Rotarix vaccine was given orally.
|
|---|---|
|
Age, Continuous
|
13.5 Weeks
STANDARD_DEVIATION 0.99 • n=5 Participants
|
|
Sex: Female, Male
Female
|
349 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
353 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not specified
|
27 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Chinese
|
366 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Malay
|
269 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Indian
|
38 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During the 4-day (Days 0-3) post-vaccination period following each dose and across dosesPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available and who filled in their symptom sheet.
Assessed solicited local and general symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Outcome measures
| Measure |
Infanrix Hexa Group
n=697 Participants
Healthy male or female subjects between and including 11 to 17 weeks of age, who were previously vaccinated with Rotarix in study 444563/028, additionally received 2 doses of Infanrix-IPV/Hib vaccine (at 3 and 4 months of age), 2 doses of Rotarix vaccine (at 2 and 4 months of age) and one dose of Infanrix Hexa vaccine (at 5 months of age) as a primary vaccination course, followed by administration of a booster dose of Infanrix-IPV/Hib vaccine (at 18 months of age). The Infanrix-IPV/Hib and Infanrix Hexa vaccines were administered intramuscularly into the right antero-lateral thigh, while the Rotarix vaccine was given orally.
|
|---|---|
|
Number of Subjects Reporting Any Solicited Local Symptoms
Any Pain, Dose 1
|
130 Participants
|
|
Number of Subjects Reporting Any Solicited Local Symptoms
Any Redness, Dose 1
|
120 Participants
|
|
Number of Subjects Reporting Any Solicited Local Symptoms
Any Swelling, Dose 1
|
89 Participants
|
|
Number of Subjects Reporting Any Solicited Local Symptoms
Any Pain, Dose 2
|
134 Participants
|
|
Number of Subjects Reporting Any Solicited Local Symptoms
Any Redness, Dose 2
|
137 Participants
|
|
Number of Subjects Reporting Any Solicited Local Symptoms
Any Swelling, Dose 2
|
100 Participants
|
|
Number of Subjects Reporting Any Solicited Local Symptoms
Any Pain, Dose 3
|
97 Participants
|
|
Number of Subjects Reporting Any Solicited Local Symptoms
Any Redness, Dose 3
|
126 Participants
|
|
Number of Subjects Reporting Any Solicited Local Symptoms
Any Swelling, Dose 3
|
100 Participants
|
|
Number of Subjects Reporting Any Solicited Local Symptoms
Any Pain, Booster dose
|
166 Participants
|
|
Number of Subjects Reporting Any Solicited Local Symptoms
Any Redness, Booster dose
|
148 Participants
|
|
Number of Subjects Reporting Any Solicited Local Symptoms
Any Swelling, Booster dose
|
115 Participants
|
|
Number of Subjects Reporting Any Solicited Local Symptoms
Any Pain, Across doses
|
301 Participants
|
|
Number of Subjects Reporting Any Solicited Local Symptoms
Any Redness, Across doses
|
273 Participants
|
|
Number of Subjects Reporting Any Solicited Local Symptoms
Any Swelling, Across doses
|
215 Participants
|
PRIMARY outcome
Timeframe: During the 4-day (Days 0-3) post-vaccination period following each dose and across dosesPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available and who filled in their symptom sheet.
Assessed solicited general symptoms were drowsiness, fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade.
Outcome measures
| Measure |
Infanrix Hexa Group
n=697 Participants
Healthy male or female subjects between and including 11 to 17 weeks of age, who were previously vaccinated with Rotarix in study 444563/028, additionally received 2 doses of Infanrix-IPV/Hib vaccine (at 3 and 4 months of age), 2 doses of Rotarix vaccine (at 2 and 4 months of age) and one dose of Infanrix Hexa vaccine (at 5 months of age) as a primary vaccination course, followed by administration of a booster dose of Infanrix-IPV/Hib vaccine (at 18 months of age). The Infanrix-IPV/Hib and Infanrix Hexa vaccines were administered intramuscularly into the right antero-lateral thigh, while the Rotarix vaccine was given orally.
|
|---|---|
|
Number of Subjects Reporting Any Solicited General Symptoms
Any Drowsiness, Dose 1
|
165 Participants
|
|
Number of Subjects Reporting Any Solicited General Symptoms
Any Temperature (Axillary) (°C), Dose 1
|
139 Participants
|
|
Number of Subjects Reporting Any Solicited General Symptoms
Any Irritability, Dose 1
|
229 Participants
|
|
Number of Subjects Reporting Any Solicited General Symptoms
Any Loss of appetite, Dose 1
|
173 Participants
|
|
Number of Subjects Reporting Any Solicited General Symptoms
Any Drowsiness, Dose 2
|
140 Participants
|
|
Number of Subjects Reporting Any Solicited General Symptoms
Any Temperature (Axillary) (°C), Dose 2
|
124 Participants
|
|
Number of Subjects Reporting Any Solicited General Symptoms
Any Irritability, Dose 2
|
192 Participants
|
|
Number of Subjects Reporting Any Solicited General Symptoms
Any Loss of appetite, Dose 2
|
155 Participants
|
|
Number of Subjects Reporting Any Solicited General Symptoms
Any Drowsiness, Dose 3
|
106 Participants
|
|
Number of Subjects Reporting Any Solicited General Symptoms
Any Temperature (Axillary) (°C), Dose 3
|
100 Participants
|
|
Number of Subjects Reporting Any Solicited General Symptoms
Any Irritability, Dose 3
|
161 Participants
|
|
Number of Subjects Reporting Any Solicited General Symptoms
Any Loss of appetite, Dose 3
|
106 Participants
|
|
Number of Subjects Reporting Any Solicited General Symptoms
Any Drowsiness, Booster dose
|
89 Participants
|
|
Number of Subjects Reporting Any Solicited General Symptoms
Any Temperature (Axillary) (°C), Booster dose
|
152 Participants
|
|
Number of Subjects Reporting Any Solicited General Symptoms
Any Irritability, Booster dose
|
163 Participants
|
|
Number of Subjects Reporting Any Solicited General Symptoms
Any Loss of appetite, Booster dose
|
118 Participants
|
|
Number of Subjects Reporting Any Solicited General Symptoms
Any Drowsiness, Across doses
|
290 Participants
|
|
Number of Subjects Reporting Any Solicited General Symptoms
Any Temperature (Axillary) (°C), Across doses
|
330 Participants
|
|
Number of Subjects Reporting Any Solicited General Symptoms
Any Irritability, Across doses
|
381 Participants
|
|
Number of Subjects Reporting Any Solicited General Symptoms
Any Loss of appetite, Across doses
|
324 Participants
|
SECONDARY outcome
Timeframe: During the 31-day (Days 0-30) post-vaccination periodPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Outcome measures
| Measure |
Infanrix Hexa Group
n=702 Participants
Healthy male or female subjects between and including 11 to 17 weeks of age, who were previously vaccinated with Rotarix in study 444563/028, additionally received 2 doses of Infanrix-IPV/Hib vaccine (at 3 and 4 months of age), 2 doses of Rotarix vaccine (at 2 and 4 months of age) and one dose of Infanrix Hexa vaccine (at 5 months of age) as a primary vaccination course, followed by administration of a booster dose of Infanrix-IPV/Hib vaccine (at 18 months of age). The Infanrix-IPV/Hib and Infanrix Hexa vaccines were administered intramuscularly into the right antero-lateral thigh, while the Rotarix vaccine was given orally.
|
|---|---|
|
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)
|
321 Participants
|
SECONDARY outcome
Timeframe: At Month 15, post-booster dosePopulation: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
A large swelling reaction was defined as swelling with a diameter greater than (\>) 50 millimeters (mm), noticeable diffuse swelling or noticeable increase of limb circumference.
Outcome measures
| Measure |
Infanrix Hexa Group
n=702 Participants
Healthy male or female subjects between and including 11 to 17 weeks of age, who were previously vaccinated with Rotarix in study 444563/028, additionally received 2 doses of Infanrix-IPV/Hib vaccine (at 3 and 4 months of age), 2 doses of Rotarix vaccine (at 2 and 4 months of age) and one dose of Infanrix Hexa vaccine (at 5 months of age) as a primary vaccination course, followed by administration of a booster dose of Infanrix-IPV/Hib vaccine (at 18 months of age). The Infanrix-IPV/Hib and Infanrix Hexa vaccines were administered intramuscularly into the right antero-lateral thigh, while the Rotarix vaccine was given orally.
|
|---|---|
|
Number of Subjects Reporting Any Large Swelling Reactions
|
0 Participants
|
SECONDARY outcome
Timeframe: During the entire study period (from Month 0 up to Month 21)Population: The analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects for whom data were available.
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Outcome measures
| Measure |
Infanrix Hexa Group
n=702 Participants
Healthy male or female subjects between and including 11 to 17 weeks of age, who were previously vaccinated with Rotarix in study 444563/028, additionally received 2 doses of Infanrix-IPV/Hib vaccine (at 3 and 4 months of age), 2 doses of Rotarix vaccine (at 2 and 4 months of age) and one dose of Infanrix Hexa vaccine (at 5 months of age) as a primary vaccination course, followed by administration of a booster dose of Infanrix-IPV/Hib vaccine (at 18 months of age). The Infanrix-IPV/Hib and Infanrix Hexa vaccines were administered intramuscularly into the right antero-lateral thigh, while the Rotarix vaccine was given orally.
|
|---|---|
|
Number of Subjects Reporting Any Serious Adverse Events (SAEs)
|
108 Participants
|
Adverse Events
Infanrix Hexa Group
Serious events: 108 serious events
Other events: 594 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Infanrix Hexa Group
n=702 participants at risk
Healthy male or female subjects between and including 11 to 17 weeks of age, who were previously vaccinated with Rotarix in study 444563/028, additionally received 2 doses of Infanrix-IPV/Hib vaccine (at 3 and 4 months of age), 2 doses of Rotarix vaccine (at 2 and 4 months of age) and one dose of Infanrix Hexa vaccine (at 5 months of age) as a primary vaccination course, followed by administration of a booster dose of Infanrix-IPV/Hib vaccine (at 18 months of age). The Infanrix-IPV/Hib and Infanrix Hexa vaccines were administered intramuscularly into the right antero-lateral thigh, while the Rotarix vaccine was given orally.
|
|---|---|
|
Injury, poisoning and procedural complications
Head injury
|
0.71%
5/702 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post-vaccination period; SAE(s): during the entire study period (Month 0 to Month 21).
The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
|
|
Injury, poisoning and procedural complications
Foreign body trauma
|
0.14%
1/702 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post-vaccination period; SAE(s): during the entire study period (Month 0 to Month 21).
The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.14%
1/702 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post-vaccination period; SAE(s): during the entire study period (Month 0 to Month 21).
The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.14%
1/702 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post-vaccination period; SAE(s): during the entire study period (Month 0 to Month 21).
The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.14%
1/702 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post-vaccination period; SAE(s): during the entire study period (Month 0 to Month 21).
The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.71%
5/702 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post-vaccination period; SAE(s): during the entire study period (Month 0 to Month 21).
The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
|
|
Respiratory, thoracic and mediastinal disorders
Asthmatic crisis
|
0.14%
1/702 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post-vaccination period; SAE(s): during the entire study period (Month 0 to Month 21).
The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
|
|
Nervous system disorders
Febrile convulsion
|
1.9%
13/702 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post-vaccination period; SAE(s): during the entire study period (Month 0 to Month 21).
The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
|
|
Nervous system disorders
Convulsion
|
0.14%
1/702 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post-vaccination period; SAE(s): during the entire study period (Month 0 to Month 21).
The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
|
|
Nervous system disorders
Status epilepticus
|
0.14%
1/702 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post-vaccination period; SAE(s): during the entire study period (Month 0 to Month 21).
The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
|
|
General disorders
Pyrexia
|
0.28%
2/702 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post-vaccination period; SAE(s): during the entire study period (Month 0 to Month 21).
The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
|
|
Gastrointestinal disorders
Colitis
|
0.14%
1/702 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post-vaccination period; SAE(s): during the entire study period (Month 0 to Month 21).
The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.14%
1/702 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post-vaccination period; SAE(s): during the entire study period (Month 0 to Month 21).
The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
|
|
Gastrointestinal disorders
Inguinal hernia, obstructive
|
0.14%
1/702 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post-vaccination period; SAE(s): during the entire study period (Month 0 to Month 21).
The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
|
|
Renal and urinary disorders
Stag horn calculus
|
0.14%
1/702 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post-vaccination period; SAE(s): during the entire study period (Month 0 to Month 21).
The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.14%
1/702 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post-vaccination period; SAE(s): during the entire study period (Month 0 to Month 21).
The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
|
|
Skin and subcutaneous tissue disorders
Urticaria papular
|
0.14%
1/702 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post-vaccination period; SAE(s): during the entire study period (Month 0 to Month 21).
The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.14%
1/702 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post-vaccination period; SAE(s): during the entire study period (Month 0 to Month 21).
The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
|
|
Infections and infestations
Bronchiolitis
|
4.3%
30/702 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post-vaccination period; SAE(s): during the entire study period (Month 0 to Month 21).
The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
|
|
Infections and infestations
Gastroenteritis
|
1.6%
11/702 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post-vaccination period; SAE(s): during the entire study period (Month 0 to Month 21).
The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.6%
11/702 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post-vaccination period; SAE(s): during the entire study period (Month 0 to Month 21).
The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
|
|
Infections and infestations
Gastritis viral
|
1.00%
7/702 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post-vaccination period; SAE(s): during the entire study period (Month 0 to Month 21).
The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
|
|
Infections and infestations
Urinary tract infection
|
0.71%
5/702 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post-vaccination period; SAE(s): during the entire study period (Month 0 to Month 21).
The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.57%
4/702 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post-vaccination period; SAE(s): during the entire study period (Month 0 to Month 21).
The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
|
|
Infections and infestations
Gastroenteritis viral
|
0.57%
4/702 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post-vaccination period; SAE(s): during the entire study period (Month 0 to Month 21).
The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
0.57%
4/702 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post-vaccination period; SAE(s): during the entire study period (Month 0 to Month 21).
The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
|
|
Infections and infestations
Cellulitis
|
0.43%
3/702 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post-vaccination period; SAE(s): during the entire study period (Month 0 to Month 21).
The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
0.43%
3/702 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post-vaccination period; SAE(s): during the entire study period (Month 0 to Month 21).
The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
|
|
Infections and infestations
Pneumonia
|
0.43%
3/702 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post-vaccination period; SAE(s): during the entire study period (Month 0 to Month 21).
The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
|
|
Infections and infestations
Abscess
|
0.28%
2/702 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post-vaccination period; SAE(s): during the entire study period (Month 0 to Month 21).
The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
|
|
Infections and infestations
Bronchitis
|
0.28%
2/702 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post-vaccination period; SAE(s): during the entire study period (Month 0 to Month 21).
The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
|
|
Infections and infestations
Bronchopneumonia
|
0.28%
2/702 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post-vaccination period; SAE(s): during the entire study period (Month 0 to Month 21).
The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
|
|
Infections and infestations
Kawasaki's disease
|
0.28%
2/702 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post-vaccination period; SAE(s): during the entire study period (Month 0 to Month 21).
The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.28%
2/702 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post-vaccination period; SAE(s): during the entire study period (Month 0 to Month 21).
The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
|
|
Infections and infestations
Pharyngitis
|
0.28%
2/702 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post-vaccination period; SAE(s): during the entire study period (Month 0 to Month 21).
The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
|
|
Infections and infestations
Viral infection
|
0.28%
2/702 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post-vaccination period; SAE(s): during the entire study period (Month 0 to Month 21).
The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
|
|
Infections and infestations
Abscess neck
|
0.14%
1/702 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post-vaccination period; SAE(s): during the entire study period (Month 0 to Month 21).
The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
|
|
Infections and infestations
Exanthema subitum
|
0.14%
1/702 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post-vaccination period; SAE(s): during the entire study period (Month 0 to Month 21).
The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
|
|
Infections and infestations
Herpangina
|
0.14%
1/702 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post-vaccination period; SAE(s): during the entire study period (Month 0 to Month 21).
The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
|
|
Infections and infestations
Influenza
|
0.14%
1/702 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post-vaccination period; SAE(s): during the entire study period (Month 0 to Month 21).
The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
|
|
Infections and infestations
Otitis media
|
0.14%
1/702 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post-vaccination period; SAE(s): during the entire study period (Month 0 to Month 21).
The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
|
|
Infections and infestations
Periorbital cellulitis
|
0.14%
1/702 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post-vaccination period; SAE(s): during the entire study period (Month 0 to Month 21).
The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.14%
1/702 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post-vaccination period; SAE(s): during the entire study period (Month 0 to Month 21).
The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
|
|
Infections and infestations
Viral pharyngitis
|
0.14%
1/702 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post-vaccination period; SAE(s): during the entire study period (Month 0 to Month 21).
The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
|
|
Infections and infestations
Viral skin infection
|
0.14%
1/702 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post-vaccination period; SAE(s): during the entire study period (Month 0 to Month 21).
The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.14%
1/702 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post-vaccination period; SAE(s): during the entire study period (Month 0 to Month 21).
The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
|
Other adverse events
| Measure |
Infanrix Hexa Group
n=702 participants at risk
Healthy male or female subjects between and including 11 to 17 weeks of age, who were previously vaccinated with Rotarix in study 444563/028, additionally received 2 doses of Infanrix-IPV/Hib vaccine (at 3 and 4 months of age), 2 doses of Rotarix vaccine (at 2 and 4 months of age) and one dose of Infanrix Hexa vaccine (at 5 months of age) as a primary vaccination course, followed by administration of a booster dose of Infanrix-IPV/Hib vaccine (at 18 months of age). The Infanrix-IPV/Hib and Infanrix Hexa vaccines were administered intramuscularly into the right antero-lateral thigh, while the Rotarix vaccine was given orally.
|
|---|---|
|
General disorders
Pain
|
43.2%
301/697 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post-vaccination period; SAE(s): during the entire study period (Month 0 to Month 21).
The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
|
|
General disorders
Redness
|
39.2%
273/697 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post-vaccination period; SAE(s): during the entire study period (Month 0 to Month 21).
The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
|
|
General disorders
Swelling
|
30.8%
215/697 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post-vaccination period; SAE(s): during the entire study period (Month 0 to Month 21).
The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
|
|
General disorders
Drowsiness
|
41.6%
290/697 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post-vaccination period; SAE(s): during the entire study period (Month 0 to Month 21).
The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
|
|
General disorders
Fever (Axillary) (°C)
|
47.3%
330/697 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post-vaccination period; SAE(s): during the entire study period (Month 0 to Month 21).
The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
|
|
General disorders
Irritability
|
54.7%
381/697 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post-vaccination period; SAE(s): during the entire study period (Month 0 to Month 21).
The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
|
|
General disorders
Loss of appetite
|
46.5%
324/697 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post-vaccination period; SAE(s): during the entire study period (Month 0 to Month 21).
The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
|
|
General disorders
Pyrexia
|
6.6%
46/702 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post-vaccination period; SAE(s): during the entire study period (Month 0 to Month 21).
The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.7%
40/702 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post-vaccination period; SAE(s): during the entire study period (Month 0 to Month 21).
The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.7%
40/702 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post-vaccination period; SAE(s): during the entire study period (Month 0 to Month 21).
The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
|
|
Infections and infestations
Upper respiratory tract infection
|
17.8%
125/702 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post-vaccination period; SAE(s): during the entire study period (Month 0 to Month 21).
The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK 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