Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants in Brazil

Study Results

Results available

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

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

354 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2009-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study will be to analyze 13-valent pneumococcal vaccine given to healthy infants in Brazil for safety and tolerability, and to determine the immune response to the vaccines.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study Evaluating Pneumococcal Vaccine in Healthy Infants

NCT00205803

Healthy Subjects Pneumococcal Infections

COMPLETED PHASE1/PHASE2

Study Evaluating 13-valent Pneumococcal Conjugate Vaccine In Healthy Infants

NCT00444457

Vaccines, Pneumococcal

COMPLETED PHASE3

Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Infants

NCT00366899

Vaccines, Pneumococcal

COMPLETED PHASE3

Study Comparing 13-valent Pneumococcal Conjugate Vaccine With 7-valent Pneumococcal Conjugate Vaccine

NCT00373958

Vaccines, Pneumococcal

COMPLETED PHASE3

Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants.

NCT00366340

Vaccines, Pneumococcal

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Vaccines, Pneumococcal Conjugate Vaccine

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

13vPnC

13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).

Group Type EXPERIMENTAL

13-Valent Pneumococcal Conjugate Vaccine (13vPnC)

Intervention Type BIOLOGICAL

7vPnC

7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).

Group Type ACTIVE_COMPARATOR

7-Valent Pneumococcal Conjugate Vaccine (7vPnc)

Intervention Type BIOLOGICAL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

13-Valent Pneumococcal Conjugate Vaccine (13vPnC)

Intervention Type BIOLOGICAL

7-Valent Pneumococcal Conjugate Vaccine (7vPnc)

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Healthy 1 month old infants
* Available for the duration of the study and reachable by telephone
* Able to complete two blood drawing procedures during the study

Exclusion Criteria

* Previous vaccination, contraindication or history of allergic reaction to vaccine or vaccine components
* Bleeding disorder, immune deficiency or significant chronic or congenital disease
* Previous receipt of blood products or immune globulin

Minimum Eligible Age

28 Days

Maximum Eligible Age

54 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes