Prevenar (13v) Infant Drug Use Investigation

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02119104
• Collaborator: (none)
• Enrollment: 1,087
• Duration (Months): 26

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Infants	Drug: Prevenar (13v)

Detailed Description

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 1087 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Prevenar (13v) Infant Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
• Study Start Date: Mar 1, 2014
• Actual Primary Completion Date: May 1, 2016
• Actual Study Completion Date: May 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Prevenar (13v)	Drug: Prevenar (13v); Prevenar (13v)

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Adverse Reactions [The entire observation period was from Day 1 of the 1st vaccination through Day 28 of the 4th vaccination.]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Months to 6 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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:

• Infants aged 2 months, inclusive, to 7 months, exclusive

• Infants with no history of administration of pneumococcal vaccines including Prevenar 13

• Infants expected to receive 4 vaccinations

Exclusion Criteria:

• Vaccines must not be performed if the vaccinee corresponds to any of the following:

• Persons in whom a past history of anaphylaxis due to an ingredient of Prevenar 13 or diphtheria toxoid is evident

• Persons with evident pyrexia

• Persons who evidently have serious acute diseases

• Besides the persons listed above, persons who are in a status inappropriate for immunization

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT02119104
• Other Study ID Numbers: B1851122
• First Posted: Apr 21, 2014
• Last Update Posted: Jun 19, 2017
• Last Verified: Mar 1, 2017

• Additional relevant MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine

Study Results

Participant Flow

Arm/Group Title	Prevenar 13
Arm/Group Description	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.
Period Title: Overall Study
STARTED	1087
COMPLETED	1071
NOT COMPLETED	16

Baseline Characteristics

Arm/Group Title	Prevenar 13
Arm/Group Description	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.
Overall Participants	1071
Age, Customized (Number) [Number]
2 to less than 3 months	937 87.5%
3 to less than 4 months	106 9.9%
4 to less than 5 months	21 2%
5 to less than 6 months	4 0.4%
6 to less than 7 months	3 0.3%
Sex: Female, Male (Count of Participants)
Female	501 46.8%
Male	570 53.2%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Adverse Reactions
Description	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.

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Prevenar 13
Arm/Group Description	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.
Measure Participants	1071
Adverse Reactions	432 40.3%
Serious Adverse Reactions	3 0.3%

Adverse Events

Adverse Event Reporting Description	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.
Arm/Group Title	Prevenar 13
Arm/Group Description	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.
All Cause Mortality
	Prevenar 13
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Prevenar 13
	Affected / at Risk (%)	# Events
Total	11/1071 (1%)
Gastrointestinal disorders
Haematochezia	1/1071 (0.1%)
General disorders
Pyrexia	1/1071 (0.1%)
Infections and infestations
Adenovirus infection	1/1071 (0.1%)
Gastroenteritis	1/1071 (0.1%)
Otitis media	1/1071 (0.1%)
Pneumonia	1/1071 (0.1%)
Pyelonephritis acute	1/1071 (0.1%)
Respiratory syncytial virus bronchiolitis	1/1071 (0.1%)
Respiratory syncytial virus bronchitis	1/1071 (0.1%)
Respiratory syncytial virus infection	1/1071 (0.1%)
Nervous system disorders
Febrile convulsion	1/1071 (0.1%)
Seizure	1/1071 (0.1%)
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation	1/1071 (0.1%)
Vascular disorders
Kawasaki's disease	1/1071 (0.1%)
Other (Not Including Serious) Adverse Events
	Prevenar 13
	Affected / at Risk (%)	# Events
Total	1026/1071 (95.8%)
Gastrointestinal disorders
Diarrhoea	14/1071 (1.3%)
General disorders
Pyrexia	248/1071 (23.2%)
Vaccination site erythema	283/1071 (26.4%)
Vaccination site swelling	248/1071 (23.2%)
Vaccination site pain	22/1071 (2.1%)
Infections and infestations
Pharyngitis	13/1071 (1.2%)
Bronchitis	16/1071 (1.5%)
Nervous system disorders
Somnolence	36/1071 (3.4%)
Psychiatric disorders
Mood altered	47/1071 (4.4%)
Insomnia	11/1071 (1%)
Irritability	12/1071 (1.1%)
Respiratory, thoracic and mediastinal disorders
Asthma	14/1071 (1.3%)
Upper respiratory tract inflammation	29/1071 (2.7%)
Skin and subcutaneous tissue disorders
Eczema	20/1071 (1.9%)
Erythema	13/1071 (1.2%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.