Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Preterm Compared to Term Infants.

Pfizer

Status and phase: Completed; Phase 4

Conditions: Immunization; 13-valent Pneumococcal Vaccine; Safety; Premature Birth

Treatments: Biological: 13-valent pneumococcal conjugate vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01193335

2009-017332-41 (EudraCT Number)

B1851037

6096A1-4001 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to describe the safety, tolerability, and immunogenicity of a 2,3,4 and 12 month schedule of the 13-valent pneumococcal conjugate vaccine when given to preterm infants with concomitant vaccines, compared to infants born at term.There will be a follow-up phase to assess the persistence of the antibody response at 24 and 36 months of age.

Enrollment: 200 patients

Sex: All

Ages: 42 to 98 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Healthy Infants between 42 and 98 days of age (approximately 2 months) at the time of enrollment.

Exclusion criteria

• Previous vaccination with pneumococcal vaccine,Haemophilus influenzae type B (Hib) conjugate vaccine, meningococcal type C conjugate vaccine, or diphtheria, tetanus, pertussis, or poliovirus vaccines.
• Previous anaphylactic reaction or allergy to any vaccine
• Contraindication to vaccination
• Known or suspected immune deficiency or immune suppression
• Major known congenital malformation or serious chronic disorder
• Significant neurological disorder
• Participation to another study

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Group 1: Preterm infants

Active Comparator group

Description:

Infant born at \< 37 weeks of gestation.

Treatment:

Biological: 13-valent pneumococcal conjugate vaccine

Biological: 13-valent pneumococcal conjugate vaccine

Group 2: Term infants

Active Comparator group

Description:

Infants born at ≥ 37 weeks of gestation

Treatment:

Biological: 13-valent pneumococcal conjugate vaccine

Biological: 13-valent pneumococcal conjugate vaccine