PCV7 in the Prevention of Nasopharyngeal Carriage of Vaccine Serotype (VT) Streptococcus Pneumoniae

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

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

NA

Total Enrollment

3281 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2014-05-31

Brief Summary

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

A parallel-group, randomized, open-label study will be performed in subjects receiving PCV7 and subjects receiving controlled vaccine Hib vaccine, to claim the efficacy of PCV7 in the prevention of NP carriage of vaccine-serotype S. pneumoniae (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F combined) in 2 to 5 years old healthy Chinese children.

Related Clinical Trials

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

A Study Assessing 13-valent Pneumococcal Conjugate Vaccine in Healthy Chinese Infants and Young Children

NCT03574389

Pneumococcal Infections Pneumococcal Conjugate Vaccine

COMPLETED PHASE3

Study Evaluating Streptococcus Pneumoniae Nasopharyngeal Carriage Rate in Children Receiving Prevnar®

NCT00488371

Pneumococcal Infections

COMPLETED

Evaluating Vaccine Responses in Healthy Infants Receiving Their Routine Primary Immunisation According to the Accelerated United Kingdom Schedule at 2, 3 and 4 Months

NCT01425372

Streptococcus Pneumoniae

COMPLETED

Safety and Immunogenicity Study of a 13-valent Pneumococcal Polysaccharide Conjugate Vaccine

NCT05092386

Pneumococcal Infections

COMPLETED PHASE1

Consistency, Immunogenicity, and Safety of Three Batches of 15-valent Pneumococcal Conjugate Vaccine

NCT05939219

Healthy Volunteers

UNKNOWN NA

Detailed Description

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

In 2005, clinical trials with PCV7 (Prevenar) were first conducted in China. In the phase 3 study involving Chinese infants, Prevenar was shown to be immunogenic, well tolerated, and safe when given either separately or concomitantly with a diphtheria, tetanus, and acellular pertussis (DTaP) vaccine at 3, 4, and 5 months of age. Controlled clinical trials elsewhere in the world showed the correlation between immunogenicity and disease prevention. In addition to the direct effect of Prevenar, immunization of children has also reduced the incidence of disease in adults. The changes are presumed to be due to reductions in nasopharyngeal carriage of vaccine serotype S. pneumoniae in children who have been vaccinated.

The purpose of this study will be to assess the effectiveness of Prevenar vaccination to reduce vaccine serotype (VT) NPC rates in Chinese children aged 2 to 5 years old.

Conditions

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

Streptococcal Pneumonia Nasopharyngeal Diseases Vaccination Adverse Event

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

NONE

Study Groups

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

PCV7 (Vaccine)

Randomized group of 1634 subjects to be administered a single dose of PCV7 (Hib vaccine offered at end of study).

Group Type EXPERIMENTAL

PCV7 (Pneumococcal 7-Valent Conjugate Vaccine)

Intervention Type BIOLOGICAL

injection 0.5 mL, single dose

Hib vaccine

Randomized group of 1634 subjects to be administered a single dose of Hib Vaccine(PCV7 vaccine offered at end of study).

Group Type ACTIVE_COMPARATOR

Hib Vaccine

Intervention Type BIOLOGICAL

Single Dose

Interventions

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

PCV7 (Pneumococcal 7-Valent Conjugate Vaccine)

injection 0.5 mL, single dose

Intervention Type BIOLOGICAL

Hib Vaccine

Single Dose

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Prevenar

Eligibility Criteria

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

Inclusion Criteria

1. Healthy children aged 2 to 5 years.
2. Evidence of a personally signed and dated informed consent document indicating that the parent(s) (or legal guardian) has been informed of all pertinent aspects of the study.
3. Subjects and parents / legal guardian/ adult caregiver who are willing and able to comply with scheduled visits, treatment plan, and other study procedures.
4. Available for entire study period and whose parent/legal guardian/adult caregiver can be reached by telephone.
5. Healthy child as determined by medical history, physical examination, and judgment of the investigator.

Exclusion Criteria

1. Previous vaccination with licensed or investigational pneumococcal vaccine.
2. Receipt of a full series or catch-up dose of licensed or investigational Hib vaccinations.
3. Contraindication to vaccination with a pneumococcal conjugate vaccine or Hib.
4. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
5. Known or suspected immune deficiency or suppression including treatment with systemic steroids, anti-metabolites, chemotherapy and immunomodulatory agents.
6. Major known congenital malformation or serious chronic disorder.
7. Malformation or injury of the nasopharynx that makes the procedure of taking a nasopharyngeal swab impossible.
8. Significant neurologic disorder including congenital neurological disease in sibling of the subject or history of seizure including febrile seizure, or significant stable or evolving disorder such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorder. Does not include resolving syndromes due to birth trauma such as Erb's palsy.
9. Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies) within 12 weeks prior to enrollment.
10. Participation in another investigational or interventional trial within the 28-day period before enrollment and during the conduct of the study. Participation in purely observational studies is acceptable.
11. Subjects whose parents or legal representative are investigational site staff members or subjects whose parents or legal representative are Pfizer employees directly involved in the conduct of the trial.

1. Subjects with current febrile illness (axillary temperature of ≥ 38.0ºC).
2. Subjects who used antibiotics within the previous 15 days.

Minimum Eligible Age

2 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Wu Jiang

Department of Immunization & Prevention,Beijing Center for Disease Control and Prevention

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Wu Jiang, Bachelor

Role: PRINCIPAL_INVESTIGATOR

Beijing Centers for Disease Control and Prevention

Locations

Explore where the study is taking place and check the recruitment status at each participating site.