Prevenar (13v) Infant Drug Use Investigation

NCT02119104 | Completed Results

• 1 other identifier: B1851122
• Study Type: observational
• Target: 1,087
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Infants

Outcome Measures

Primary Outcomes (1)

• 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.

  The entire observation period was from Day 1 of the 1st vaccination through Day 28 of the 4th vaccination.

Study Arms (1)

Prevenar (13v)

Drug: Prevenar (13v)

Interventions

Prevenar (13v) DRUG

Prevenar (13v)

Prevenar (13v)

Eligibility Criteria

• Age: 2 Months - 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Related Links

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

MeSH Terms

Interventions

Heptavalent Pneumococcal Conjugate Vaccine

Intervention Hierarchy (Ancestors)

Pneumococcal Vaccines; Streptococcal Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Vaccines, Combined

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2014
• First Posted: April 21, 2014
• Study Start: March 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: June 19, 2017
• Results First Posted: June 19, 2017

Record last verified: 2017-03