Trial Outcomes & Findings for Post-Marketing Study of the Safety of Prevenar (Pneumococcal Conjugate Vaccine, 7-valent) (NCT NCT00683410)
NCT ID: NCT00683410
Last Updated: 2010-11-16
Results Overview
Recruitment status
COMPLETED
Target enrollment
3366 participants
Primary outcome timeframe
30 days post injection up to 3 years
Results posted on
2010-11-16
Participant Flow
Participant milestones
| Measure |
Prevenar 7v
Pneumococcal conjugate vaccine, 7-valent, 0.5 mL intramuscular injection
|
|---|---|
|
Overall Study
STARTED
|
3366
|
|
Overall Study
Vaccinated Dose 1
|
3240
|
|
Overall Study
Vaccinated Dose 2
|
1623
|
|
Overall Study
Vaccinated Dose 3
|
817
|
|
Overall Study
Vaccinated Dose 4
|
175
|
|
Overall Study
COMPLETED
|
3366
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Post-Marketing Study of the Safety of Prevenar (Pneumococcal Conjugate Vaccine, 7-valent)
Baseline characteristics by cohort
| Measure |
Prevenar 7v
n=3366 Participants
Pneumococcal conjugate vaccine, 7-valent, 0.5 mL intramuscular injection
|
|---|---|
|
Age Continuous
|
43.6 weeks
STANDARD_DEVIATION 50.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1576 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1790 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 days post injection up to 3 yearsPopulation: Safety Analysis set - all participants who received at least one dose of Prevenar
Outcome measures
| Measure |
Prevenar 7v
n=3366 Participants
Pneumococcal conjugate vaccine, 7-valent, 0.5 mL intramuscular injection
|
|---|---|
|
Number of Participants With Spontaneous Adverse Events
|
91 Participants
|
Adverse Events
Prevenar 7v
Serious events: 3 serious events
Other events: 88 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Prevenar 7v
n=3366 participants at risk
Pneumococcal conjugate vaccine, 7-valent, 0.5 mL intramuscular injection
|
|---|---|
|
General disorders
Pyrexia
|
0.03%
1/3366 • 30 days following each vaccination
|
|
Nervous system disorders
Convulsion
|
0.03%
1/3366 • 30 days following each vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.03%
1/3366 • 30 days following each vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.03%
1/3366 • 30 days following each vaccination
|
Other adverse events
| Measure |
Prevenar 7v
n=3366 participants at risk
Pneumococcal conjugate vaccine, 7-valent, 0.5 mL intramuscular injection
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.06%
2/3366 • 30 days following each vaccination
|
|
Gastrointestinal disorders
Vomiting
|
0.03%
1/3366 • 30 days following each vaccination
|
|
General disorders
Feeling abnormal
|
0.03%
1/3366 • 30 days following each vaccination
|
|
General disorders
Injection site swelling
|
0.09%
3/3366 • 30 days following each vaccination
|
|
General disorders
Irritability
|
0.03%
1/3366 • 30 days following each vaccination
|
|
General disorders
Lethargy
|
0.03%
1/3366 • 30 days following each vaccination
|
|
General disorders
Pyrexia
|
1.1%
36/3366 • 30 days following each vaccination
|
|
Infections and infestations
Exanthema subitum
|
0.06%
2/3366 • 30 days following each vaccination
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.03%
1/3366 • 30 days following each vaccination
|
|
Nervous system disorders
Febrile convulsion
|
0.03%
1/3366 • 30 days following each vaccination
|
|
Nervous system disorders
Somnolence
|
0.03%
1/3366 • 30 days following each vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.21%
7/3366 • 30 days following each vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiolitis
|
0.21%
7/3366 • 30 days following each vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis acute
|
0.03%
1/3366 • 30 days following each vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.30%
10/3366 • 30 days following each vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Infantile asthma
|
0.06%
2/3366 • 30 days following each vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
0.24%
8/3366 • 30 days following each vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
0.15%
5/3366 • 30 days following each vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
0.68%
23/3366 • 30 days following each vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Viral rhinitis
|
0.03%
1/3366 • 30 days following each vaccination
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.12%
4/3366 • 30 days following each vaccination
|
|
Skin and subcutaneous tissue disorders
Rash pustular
|
0.03%
1/3366 • 30 days following each vaccination
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER