13vPnC Multidose Vial Safety, Tolerability and Immunogenicity Study in Healthy Infants.

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-09-30

Brief Summary

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This study will compare the immune responses of the infants who have been given 13vPnC in the mutidose vial formulation to the immune reponses of the infants who have been given 13vPnC in the single-dose syringe formulation.

It will also evaluate the safety of 13-valent pneumococcal conjugate vaccine (13vPnC) in all infants who are vaccinated.

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Detailed Description

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Conditions

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Pneumococcal Vaccines

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Multidose Vial Group

Subjects will receive three doses of 13-valent pneumococcal conjugate vaccine in the multidose vial formulation. Each dose is 0.5 mL

Group Type EXPERIMENTAL

13-valent pneumococcal conjugate vaccine

Intervention Type BIOLOGICAL

Subjects will receive three doses (0.5 mL each) of 13-valent pneumococcal conjugate vaccine (multidose vial formulation) in the anterolateral thigh muscle of the left leg. Dose 1 is administered between 42 and 70 days of age, dose 2 is administered 28 to 42 days after dose 1, dose 3 is administered 28 to 42 days after dose 2.

Single-Dose Syringe Group

Subjects will receive three doses of 13-valent pneumococcal conjugate vaccine in the single-dose syringe formulation. Each dose is 0.5 mL

Group Type ACTIVE_COMPARATOR

13-valent pneumococcal conjugate vaccine

Intervention Type BIOLOGICAL

Subjects will receive three doses (0.5 mL each) of 13-valent pneumococcal conjugate vaccine (single-dose syringe formulation) in the anterolateral thigh muscle of the left leg. Dose 1 is administered between 42 and 70 days of age, dose 2 is administered 28 to 42 days after dose 1, dose 3 is administered 28 to 42 days after dose 2.

Interventions

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13-valent pneumococcal conjugate vaccine

Subjects will receive three doses (0.5 mL each) of 13-valent pneumococcal conjugate vaccine (multidose vial formulation) in the anterolateral thigh muscle of the left leg. Dose 1 is administered between 42 and 70 days of age, dose 2 is administered 28 to 42 days after dose 1, dose 3 is administered 28 to 42 days after dose 2.

Intervention Type BIOLOGICAL

13-valent pneumococcal conjugate vaccine

Subjects will receive three doses (0.5 mL each) of 13-valent pneumococcal conjugate vaccine (single-dose syringe formulation) in the anterolateral thigh muscle of the left leg. Dose 1 is administered between 42 and 70 days of age, dose 2 is administered 28 to 42 days after dose 1, dose 3 is administered 28 to 42 days after dose 2.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Aged 42 to 70 days at enrollment.
* Determined by medical history, physical examination, and clinical judgment to be eligible for the study
* Weight of 3.5 kg or greater at the time of enrollment

Exclusion Criteria

* Previous vaccination with licensed or investigational pneumococcal vaccine.
* A previous anaphylactic reaction to any vaccine or vaccine-related component.
* Contraindication to vaccination with pneumococcal conjugate vaccine.
* Receipt of blood products or gamma-globulin since birth

Minimum Eligible Age

42 Days

Maximum Eligible Age

70 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes