Trial Outcomes & Findings for Prevenar (13v) Infant Drug Use Investigation (NCT NCT02119104)
NCT ID: NCT02119104
Last Updated: 2017-06-19
Results Overview
An adverse reaction (vaccine-related adverse event) was any untoward medical occurrence which was considered to be related to Prevenar 13 in a participant who received Prevenar 13.
Recruitment status
COMPLETED
Target enrollment
1087 participants
Primary outcome timeframe
The entire observation period was from Day 1 of the 1st vaccination through Day 28 of the 4th vaccination.
Results posted on
2017-06-19
Participant Flow
Participant milestones
| Measure |
Prevenar 13
Participants were vaccinated with Prevenar 13 as follows: for primary immunization, three doses of Prevenar 13 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
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|---|---|
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Overall Study
STARTED
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1087
|
|
Overall Study
COMPLETED
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1071
|
|
Overall Study
NOT COMPLETED
|
16
|
Reasons for withdrawal
| Measure |
Prevenar 13
Participants were vaccinated with Prevenar 13 as follows: for primary immunization, three doses of Prevenar 13 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
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|---|---|
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Overall Study
Protocol Violation
|
16
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Baseline Characteristics
Prevenar (13v) Infant Drug Use Investigation
Baseline characteristics by cohort
| Measure |
Prevenar 13
n=1071 Participants
Participants were vaccinated with Prevenar 13 as follows: for primary immunization, three doses of Prevenar 13 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
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|---|---|
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Age, Customized
2 to less than 3 months
|
937 Participants
n=113 Participants
|
|
Age, Customized
3 to less than 4 months
|
106 Participants
n=113 Participants
|
|
Age, Customized
4 to less than 5 months
|
21 Participants
n=113 Participants
|
|
Age, Customized
5 to less than 6 months
|
4 Participants
n=113 Participants
|
|
Age, Customized
6 to less than 7 months
|
3 Participants
n=113 Participants
|
|
Sex: Female, Male
Female
|
501 Participants
n=113 Participants
|
|
Sex: Female, Male
Male
|
570 Participants
n=113 Participants
|
PRIMARY outcome
Timeframe: The entire observation period was from Day 1 of the 1st vaccination through Day 28 of the 4th vaccination.Population: The safety analysis population comprised of participants who had received Prevenar 13 at least once and provided the safety data and who did not meet the exclusion criteria for the safety analysis.
An adverse reaction (vaccine-related adverse event) was any untoward medical occurrence which was considered to be related to Prevenar 13 in a participant who received Prevenar 13.
Outcome measures
| Measure |
Prevenar 13
n=1071 Participants
Participants were vaccinated with Prevenar 13 as follows: for primary immunization, three doses of Prevenar 13 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
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|---|---|
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Number of Participants With Adverse Reactions
Adverse Reactions
|
432 Participants
|
|
Number of Participants With Adverse Reactions
Serious Adverse Reactions
|
3 Participants
|
Adverse Events
Prevenar 13
Serious events: 11 serious events
Other events: 1026 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Prevenar 13
n=1071 participants at risk
Participants were vaccinated with Prevenar 13 as follows: for primary immunization, three doses of Prevenar 13 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
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|---|---|
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Infections and infestations
Adenovirus infection
|
0.09%
1/1071
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Gastroenteritis
|
0.09%
1/1071
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Otitis media
|
0.09%
1/1071
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pneumonia
|
0.09%
1/1071
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pyelonephritis acute
|
0.09%
1/1071
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
0.09%
1/1071
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Respiratory syncytial virus bronchitis
|
0.09%
1/1071
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.09%
1/1071
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Febrile convulsion
|
0.09%
1/1071
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Seizure
|
0.09%
1/1071
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Kawasaki's disease
|
0.09%
1/1071
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.09%
1/1071
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Haematochezia
|
0.09%
1/1071
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Pyrexia
|
0.09%
1/1071
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
Prevenar 13
n=1071 participants at risk
Participants were vaccinated with Prevenar 13 as follows: for primary immunization, three doses of Prevenar 13 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
|
|---|---|
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Nervous system disorders
Somnolence
|
3.4%
36/1071
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Mood altered
|
4.4%
47/1071
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Pyrexia
|
23.2%
248/1071
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Vaccination site erythema
|
26.4%
283/1071
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Vaccination site swelling
|
23.2%
248/1071
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pharyngitis
|
1.2%
13/1071
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Bronchitis
|
1.5%
16/1071
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Insomnia
|
1.0%
11/1071
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Irritability
|
1.1%
12/1071
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.3%
14/1071
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
2.7%
29/1071
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.3%
14/1071
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.9%
20/1071
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.2%
13/1071
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Vaccination site pain
|
2.1%
22/1071
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
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