NCT02133469

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,281

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2012

Typical duration for not_applicable

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

May 7, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 8, 2014

Completed
Last Updated

May 20, 2016

Status Verified

May 1, 2014

Enrollment Period

1.8 years

First QC Date

May 7, 2014

Last Update Submit

May 19, 2016

Conditions

Streptococcal PneumoniaNasopharyngeal DiseasesVaccination Adverse Event

Keywords

EffectivenessPrevenarnasopharyngeal carriagevaccine serotype

Outcome Measures

Primary Outcomes (1)

  • Carriage Rate of Vaccine-Serotype S. pneumoniae at 180days after vaccination

    6 months

Secondary Outcomes (10)

  • Carriage Rate of vaccine-serotype S. pneumoniae in PCV7 group versus Hib group.

    60 days

  • Carriage rate of non-vaccine serotype S. pneumoniae in PCV7 group versus Hib group.

    Baseline before vaccination

  • Carriage rate of non-vaccine serotype S. pneumoniae in PCV7 group versus Hib group.

    60 days after vaccination

  • Carriage rate of non-vaccine serotype S. pneumoniae in PCV7 group versus Hib group.

    6 months after vaccination

  • Carriage rate of individual serotype S. pneumoniae in PCV7 group and Hib group.

    Baseline before vaccination

  • +5 more secondary outcomes

Study Arms (2)

PCV7 (Vaccine)

EXPERIMENTAL

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

Biological: PCV7 (Pneumococcal 7-Valent Conjugate Vaccine)

Hib vaccine

ACTIVE COMPARATOR

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

Biological: Hib Vaccine

Interventions

PCV7 (Pneumococcal 7-Valent Conjugate Vaccine)BIOLOGICAL

injection 0.5 mL, single dose

Also known as: Prevenar
PCV7 (Vaccine)
Hib VaccineBIOLOGICAL

Single Dose

Hib vaccine

Eligibility Criteria

Age2 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy children aged 2 to 5 years.
  • 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.
  • Subjects and parents / legal guardian/ adult caregiver who are willing and able to comply with scheduled visits, treatment plan, and other study procedures.
  • Available for entire study period and whose parent/legal guardian/adult caregiver can be reached by telephone.
  • Healthy child as determined by medical history, physical examination, and judgment of the investigator.

You may not qualify if:

  • Previous vaccination with licensed or investigational pneumococcal vaccine.
  • Receipt of a full series or catch-up dose of licensed or investigational Hib vaccinations.
  • Contraindication to vaccination with a pneumococcal conjugate vaccine or Hib.
  • Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
  • Known or suspected immune deficiency or suppression including treatment with systemic steroids, anti-metabolites, chemotherapy and immunomodulatory agents.
  • Major known congenital malformation or serious chronic disorder.
  • Malformation or injury of the nasopharynx that makes the procedure of taking a nasopharyngeal swab impossible.
  • 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.
  • Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies) within 12 weeks prior to enrollment.
  • 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.
  • 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.
  • Subjects with current febrile illness (axillary temperature of ≥ 38.0ºC).
  • Subjects who used antibiotics within the previous 15 days.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Huairou District Center for Disease Prevention and Control

Beijing, Beijing Municipality, 101400, China

Location

Daxing District Center for Disease Prevention and Control

Beijing, Beijing Municipality, 102600, China

Location

Chongwen District Center for Disease Control and Prevention

Beijing, Beijing Municipality, China

Location

Shijingshan District Center for Disease Control and Prevention

Beijing, Beijing Municipality, China

Location

Xuanwu District Center for Disease Control and Prevention

Beijing, Beijing Municipality, China

Location

Chaoyang District Center for Disease Control and Prevention

Chaoyang District, Beijing Municipality, China

Location

Dongcheng District Center for Disease Control and Prevention

Dongcheng District, Beijing Municipality, China

Location

Fengtai District Center for Disease Control and Prevention

Fengtai District, Beijing Municipality, China

Location

Xicheng District Center for Disease Prevention and Control

Xicheng District, Beijing Municipality, 100120, China

Location

MeSH Terms

Conditions

PneumoniaNasopharyngeal Diseases

Interventions

Pneumococcal VaccinesHeptavalent Pneumococcal Conjugate VaccineHibTITER protein, Haemophilus influenzae

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Streptococcal VaccinesBacterial VaccinesVaccinesBiological ProductsComplex MixturesVaccines, Combined

Study Officials

  • Wu Jiang, Bachelor

    Beijing Centers for Disease Control and Prevention

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Immunization & Prevention,Beijing Center for Disease Control and Prevention

Study Record Dates

First Submitted

May 7, 2014

First Posted

May 8, 2014

Study Start

June 1, 2012

Primary Completion

April 1, 2014

Study Completion

May 1, 2014

Last Updated

May 20, 2016

Record last verified: 2014-05

Locations

CN(9)