Study Evaluating 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Healthy Children Aged 15 Months to 17 Years

Pfizer

Status and phase: Completed; Phase 3

Conditions: Healthy Subjects

Treatments: Biological: 13 valent pneumococcal conjugate vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00761631

6096A1-3011

Details and patient eligibility

About

This open-label, multicenter study is designed to evaluate the safety, tolerability and immunogenicity of 13-valent pneumococcal conjugate vaccine in healthy children aged more than 15 months up to less than 18 years.

Enrollment: 1,200 patients

Sex: All

Ages: 15 months to 17 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or female subjects >15months to <18years in good health, available for entire study period and reachable by phone, parents/legal guardian able and willing to complete all study procedures, written documentation from health professional showing prior vaccination with Prevnar (except for group 4).

Group 4 only:

• Negative urine pregnancy test for female subjects who are menstruating.

Exclusion criteria

• Previous reaction or contra-indication to pneumococcal vaccine or vaccine related component , bleeding diathesis, received blood transfusion or blood related products, immune deficiency,congenital malformation.

Group 4 only:

• Previous vaccination with Prevnar or any other pneumococcal vaccine.
• Pregnant or breastfeeding adolescent females.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

1,200 participants in 1 patient group

Single

Experimental group

Description:

Open label

Treatment:

Biological: 13 valent pneumococcal conjugate vaccine