An observational study in Infants, sponsored by Pfizer. Completed. Open to participants aged 2 Months to 6 Months. Per ClinicalTrials.gov, last updated 2017-06-19.
Sponsored by Pfizer · Observational
The purpose of this study is to investigate post marketing use and safety of Prevnar ( 13v) in infants vaccinated for the first time at the age of 2 months, inclusive, to 7 months, exclusive.
The investigation will be conducted using the continuous investigation method, with which a satisfying registration conditions will be continuously registered until the number of contracted cases is reached.
Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Vaccinees who meet all of the following conditions at the time of the first vaccination among infants who use Prevenar 13 in accordance with the indication, and dosage and administration of the vaccine will be included in the investigation.
Exclusion Criteria:
Drug: Prevenar (13v)
Prevenar (13v)
Number of Participants With Adverse Reactions
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.
Time frame: The entire observation period was from Day 1 of the 1st vaccination through Day 28 of the 4th vaccination.
| Milestone | Prevenar 13 |
|---|---|
| Started | 1087 |
| Completed | 1071 |
| Not completed | 16 |
| Withdrew: Protocol violation | 16 |
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.
| Participants | Prevenar 13 |
|---|---|
| Adverse Reactions | 432 |
| Serious Adverse Reactions | 3 |
Non-serious events are listed at a 1.0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Prevenar 13 | — | 11/1,071 (1%) | 1,026/1,071 (95.8%) |
| Event | Prevenar 13 |
|---|---|
| Adenovirus infectionInfections and infestations | 1/1071 |
| GastroenteritisInfections and infestations | 1/1071 |
| Otitis mediaInfections and infestations | 1/1071 |
| PneumoniaInfections and infestations | 1/1071 |
| Pyelonephritis acuteInfections and infestations | 1/1071 |
| Respiratory syncytial virus bronchiolitisInfections and infestations | 1/1071 |
| Respiratory syncytial virus bronchitisInfections and infestations | 1/1071 |
| Respiratory syncytial virus infectionInfections and infestations | 1/1071 |
| Febrile convulsionNervous system disorders | 1/1071 |
| SeizureNervous system disorders | 1/1071 |
| Event | Prevenar 13 |
|---|---|
| Vaccination site erythemaGeneral disorders | 283/1071 |
| PyrexiaGeneral disorders | 248/1071 |
| Vaccination site swellingGeneral disorders | 248/1071 |
| Mood alteredPsychiatric disorders | 47/1071 |
| SomnolenceNervous system disorders | 36/1071 |
| Upper respiratory tract inflammationRespiratory, thoracic and mediastinal disorders | 29/1071 |
| Vaccination site painGeneral disorders | 22/1071 |
| EczemaSkin and subcutaneous tissue disorders | 20/1071 |
| BronchitisInfections and infestations | 16/1071 |
| AsthmaRespiratory, thoracic and mediastinal disorders | 14/1071 |
In total, 1087 participants were registered in this study. Of the 1087 participants, 16 participants were excluded from the safety analysis for the reasons of protocol violation.
| Age, Customized(Participants) | Prevenar 13 |
|---|---|
| 2 to less than 3 months | 937 |
| 3 to less than 4 months | 106 |
| 4 to less than 5 months | 21 |
| 5 to less than 6 months | 4 |
| 6 to less than 7 months | 3 |
| Sex: Female, Male(Participants) | Prevenar 13 |
|---|---|
| Female | 501 |
| Male | 570 |
No study locations are listed for this record.
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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