Trial Outcomes & Findings for Assess the Safety & Reactogenicity of DTPa-IPV/Hib Vaccine Administered at 3, 4, 5 & 18 Mths of Age, in Healthy Infants (NCT NCT00325156)
NCT ID: NCT00325156
Last Updated: 2020-01-02
Results Overview
Assessed solicited local and general symptoms were pain, redness, swelling, drowsiness, fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C )\], irritability and loss of appetite. Any was defined as any report of the specified symptom irrespective of intensity grade and relationship to vaccination.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
2590 participants
Primary outcome timeframe
During the 4-day (Days 0-3) post-vaccination period, across doses
Results posted on
2020-01-02
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-IPV+Hib Group
Healthy male or female subjects between and including 11 to 17 weeks of age at the time of first vaccination, who previously participated in a human rotavirus (HRV) study (444563/028), received 3 primary doses and one booster dose of Infanrix™-IPV/Hib vaccine at 3,4 and 5 months of age and 18 months of age, respectively, administered intramuscularly into the anterolateral thigh. Subjects also received 2 oral doses of Rotarix™ (HRV) vaccine or placebo, at 3 and 4 months of age.
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|---|---|
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Overall Study
STARTED
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2590
|
|
Overall Study
COMPLETED
|
2478
|
|
Overall Study
NOT COMPLETED
|
112
|
Reasons for withdrawal
| Measure |
Infanrix-IPV+Hib Group
Healthy male or female subjects between and including 11 to 17 weeks of age at the time of first vaccination, who previously participated in a human rotavirus (HRV) study (444563/028), received 3 primary doses and one booster dose of Infanrix™-IPV/Hib vaccine at 3,4 and 5 months of age and 18 months of age, respectively, administered intramuscularly into the anterolateral thigh. Subjects also received 2 oral doses of Rotarix™ (HRV) vaccine or placebo, at 3 and 4 months of age.
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|---|---|
|
Overall Study
Protocol Violation
|
8
|
|
Overall Study
Lost to follow-up (complete vaccination)
|
41
|
|
Overall Study
Migrated/moved from study area
|
12
|
|
Overall Study
Adverse event, non-fatal
|
3
|
|
Overall Study
Lost to follow-up (incompl. vaccination)
|
16
|
|
Overall Study
Other
|
1
|
|
Overall Study
Withdrawal by Subject
|
31
|
Baseline Characteristics
Assess the Safety & Reactogenicity of DTPa-IPV/Hib Vaccine Administered at 3, 4, 5 & 18 Mths of Age, in Healthy Infants
Baseline characteristics by cohort
| Measure |
Infanrix-IPV+ Hib Group
n=2590 Participants
Healthy male or female subjects between and including 11 to 17 weeks of age at the time of first vaccination, who previously participated in a human rotavirus (HRV) study (444563/028), received 3 primary doses and one booster dose of Infanrix™-IPV/Hib vaccine at 3,4 and 5 months of age and 18 months of age, respectively, administered intramuscularly into the anterolateral thigh. Subjects also received 2 oral doses of Rotarix™ (HRV) vaccine or placebo, at 3 and 4 months of age.
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|---|---|
|
Age, Continuous
|
13.3 Weeks
STANDARD_DEVIATION 0.87 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1245 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1345 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During the 4-day (Days 0-3) post-vaccination period, across dosesPopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had filled-in the symptom sheet.
Assessed solicited local and general symptoms were pain, redness, swelling, drowsiness, fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C )\], irritability and loss of appetite. Any was defined as any report of the specified symptom irrespective of intensity grade and relationship to vaccination.
Outcome measures
| Measure |
Infanrix-IPV+Hib Group
n=2580 Participants
Healthy male or female subjects between and including 11 to 17 weeks of age at the time of first vaccination, who previously participated in a human rotavirus (HRV) study (444563/028), received 3 primary doses and one booster dose of Infanrix™-IPV/Hib vaccine at 3,4 and 5 months of age and 18 months of age, respectively, administered intramuscularly into the anterolateral thigh. Subjects also received 2 oral doses of Rotarix™ (HRV) vaccine or placebo, at 3 and 4 months of age.
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|---|---|
|
Number of Subjects Reporting Any Solicited Local and General Symptoms
Any Pain, Across doses
|
855 Subjects
|
|
Number of Subjects Reporting Any Solicited Local and General Symptoms
Any Redness, Across doses
|
907 Subjects
|
|
Number of Subjects Reporting Any Solicited Local and General Symptoms
Any Swelling, Across doses
|
706 Subjects
|
|
Number of Subjects Reporting Any Solicited Local and General Symptoms
Any Drowsiness, Across doses
|
929 Subjects
|
|
Number of Subjects Reporting Any Solicited Local and General Symptoms
Any Fever (Axillary/≥ 37.5°C), Across doses
|
1482 Subjects
|
|
Number of Subjects Reporting Any Solicited Local and General Symptoms
Any Irritability, Across doses
|
1217 Subjects
|
|
Number of Subjects Reporting Any Solicited Local and General Symptoms
Any Loss of appetite, Across doses
|
1010 Subjects
|
SECONDARY outcome
Timeframe: During the 30-day (Days 0-29) 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-IPV+Hib Group
n=2590 Participants
Healthy male or female subjects between and including 11 to 17 weeks of age at the time of first vaccination, who previously participated in a human rotavirus (HRV) study (444563/028), received 3 primary doses and one booster dose of Infanrix™-IPV/Hib vaccine at 3,4 and 5 months of age and 18 months of age, respectively, administered intramuscularly into the anterolateral thigh. Subjects also received 2 oral doses of Rotarix™ (HRV) vaccine or placebo, at 3 and 4 months of age.
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|---|---|
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Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)
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914 Subjects
|
SECONDARY outcome
Timeframe: At Month 18, post-booster dosePopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had filled-in the symptom sheet.
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-IPV+Hib Group
n=2540 Participants
Healthy male or female subjects between and including 11 to 17 weeks of age at the time of first vaccination, who previously participated in a human rotavirus (HRV) study (444563/028), received 3 primary doses and one booster dose of Infanrix™-IPV/Hib vaccine at 3,4 and 5 months of age and 18 months of age, respectively, administered intramuscularly into the anterolateral thigh. Subjects also received 2 oral doses of Rotarix™ (HRV) vaccine or placebo, at 3 and 4 months of age.
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|---|---|
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Number of Subjects Reporting Large Injection Site Swelling
Local swelling
|
10 Subjects
|
|
Number of Subjects Reporting Large Injection Site Swelling
Diffuse swelling
|
1 Subjects
|
SECONDARY outcome
Timeframe: During the entire study periodPopulation: 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-IPV+Hib Group
n=2590 Participants
Healthy male or female subjects between and including 11 to 17 weeks of age at the time of first vaccination, who previously participated in a human rotavirus (HRV) study (444563/028), received 3 primary doses and one booster dose of Infanrix™-IPV/Hib vaccine at 3,4 and 5 months of age and 18 months of age, respectively, administered intramuscularly into the anterolateral thigh. Subjects also received 2 oral doses of Rotarix™ (HRV) vaccine or placebo, at 3 and 4 months of age.
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|---|---|
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Number of Subjects Reporting Any Serious Adverse Events (SAEs)
|
380 Subjects
|
Adverse Events
Infanrix-IPV+Hib Group
Serious events: 380 serious events
Other events: 2167 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Infanrix-IPV+Hib Group
n=2590 participants at risk
Healthy male or female subjects between and including 11 to 17 weeks of age at the time of first vaccination, who previously participated in a human rotavirus (HRV) study (444563/028), received 3 primary doses and one booster dose of Infanrix™-IPV/Hib vaccine at 3,4 and 5 months of age and 18 months of age, respectively, administered intramuscularly into the anterolateral thigh. Subjects also received 2 oral doses of Rotarix™ (HRV) vaccine or placebo, at 3 and 4 months of age.
|
|---|---|
|
Vascular disorders
Kawasaki's disease
|
0.23%
6/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Vascular disorders
Haematoma
|
0.08%
2/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Immune system disorders
Milk allergy
|
0.04%
1/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
General disorders
Pyrexia
|
0.04%
1/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
General disorders
Swelling
|
0.04%
1/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Reproductive system and breast disorders
Balanitis
|
0.08%
2/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.46%
12/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Injury, poisoning and procedural complications
Foreign body trauma
|
0.12%
3/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.12%
3/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.08%
2/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.08%
2/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Injury, poisoning and procedural complications
Accidental exposure
|
0.04%
1/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.04%
1/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.04%
1/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.04%
1/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.04%
1/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.04%
1/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Cardiac disorders
Cardiac aneurysm
|
0.04%
1/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Congenital, familial and genetic disorders
Cryptorchism
|
0.04%
1/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Congenital, familial and genetic disorders
Laryngomalacia
|
0.04%
1/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Congenital, familial and genetic disorders
Lymphangioma
|
0.04%
1/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.42%
11/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.08%
2/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.08%
2/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Respiratory, thoracic and mediastinal disorders
Asthmatic crisis
|
0.04%
1/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.04%
1/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.04%
1/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.04%
1/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Blood and lymphatic system disorders
Idiopathic thrombocytopenic purpura
|
0.04%
1/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.04%
1/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.04%
1/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Nervous system disorders
Febrile convulsion
|
0.97%
25/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Nervous system disorders
Convulsion
|
0.27%
7/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Nervous system disorders
Benign intracranial hypertension
|
0.04%
1/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.04%
1/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Gastrointestinal disorders
Gastritis
|
0.19%
5/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.12%
3/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Gastrointestinal disorders
Intussusception
|
0.08%
2/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Gastrointestinal disorders
Constipation
|
0.04%
1/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Gastrointestinal disorders
Haematemesis
|
0.04%
1/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.04%
1/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Gastrointestinal disorders
Vomiting
|
0.04%
1/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Renal and urinary disorders
Vesicoureteric reflux
|
0.04%
1/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.12%
3/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.04%
1/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.04%
1/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Skin and subcutaneous tissue disorders
Urticaria chronic
|
0.04%
1/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.08%
2/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.08%
2/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.04%
1/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Infections and infestations
Bronchiolitis
|
3.4%
87/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.8%
47/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Infections and infestations
Gastroenteritis
|
1.7%
45/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Infections and infestations
Bronchitis
|
0.77%
20/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Infections and infestations
Gastritis viral
|
0.62%
16/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Infections and infestations
Urinary tract infection
|
0.62%
16/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.50%
13/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
0.50%
13/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Infections and infestations
Viral infection
|
0.50%
13/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Infections and infestations
Gastroenteritis viral
|
0.46%
12/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
0.39%
10/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.27%
7/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Infections and infestations
Herpangina
|
0.27%
7/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Infections and infestations
Pneumonia
|
0.27%
7/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Infections and infestations
Abscess limb
|
0.23%
6/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Infections and infestations
Pharyngitis
|
0.23%
6/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.23%
6/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.19%
5/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Infections and infestations
Lobar pneumonia
|
0.15%
4/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.15%
4/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Infections and infestations
Viral skin infection
|
0.15%
4/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Infections and infestations
Subcutaneous abscess
|
0.12%
3/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Infections and infestations
Bronchopneumonia
|
0.08%
2/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Infections and infestations
Croup infectious
|
0.08%
2/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Infections and infestations
Haematoma infection
|
0.08%
2/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Infections and infestations
Otitis media
|
0.08%
2/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Infections and infestations
Perianal abscess
|
0.08%
2/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Infections and infestations
Abscess
|
0.04%
1/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Infections and infestations
Acarodermatitis
|
0.04%
1/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Infections and infestations
Bacteraemia
|
0.04%
1/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.04%
1/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Infections and infestations
Cellulitis
|
0.04%
1/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Infections and infestations
Conjunctivitis viral
|
0.04%
1/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Infections and infestations
Dengue fever
|
0.04%
1/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Infections and infestations
Epstein-barr virus infection
|
0.04%
1/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Infections and infestations
Exanthema subitum
|
0.04%
1/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Infections and infestations
Folliculitis
|
0.04%
1/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Infections and infestations
Gastroenteritis bacterial
|
0.04%
1/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Infections and infestations
Influenza
|
0.04%
1/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Infections and infestations
Localised infection
|
0.04%
1/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Infections and infestations
Lymphadenitis bacterial
|
0.04%
1/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Infections and infestations
Necrotising fasciitis
|
0.04%
1/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Infections and infestations
Parainfluenzae viral laryngotracheobronchitis
|
0.04%
1/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Infections and infestations
Parotitis
|
0.04%
1/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Infections and infestations
Tonsillitis
|
0.04%
1/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.04%
1/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Infections and infestations
Viral pharyngitis
|
0.04%
1/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
Other adverse events
| Measure |
Infanrix-IPV+Hib Group
n=2590 participants at risk
Healthy male or female subjects between and including 11 to 17 weeks of age at the time of first vaccination, who previously participated in a human rotavirus (HRV) study (444563/028), received 3 primary doses and one booster dose of Infanrix™-IPV/Hib vaccine at 3,4 and 5 months of age and 18 months of age, respectively, administered intramuscularly into the anterolateral thigh. Subjects also received 2 oral doses of Rotarix™ (HRV) vaccine or placebo, at 3 and 4 months of age.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.6%
146/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
General disorders
Pain
|
33.0%
855/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
General disorders
Redness
|
35.0%
907/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
General disorders
Swelling
|
27.3%
706/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
General disorders
Drowsiness
|
35.9%
929/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
General disorders
Fever (Axillary)
|
57.2%
1482/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
General disorders
Irritability
|
47.0%
1217/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
General disorders
Loss of appetite
|
39.0%
1010/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
|
Infections and infestations
Upper respiratory tract infection
|
15.1%
391/2590 • Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
|
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