Efficacy Trial of Two Pneumococcal Conjugate Vaccines (Pn... | NCT00378417

ID	Type	Description	Link
PNC95KTL

Status Module

Record Verification Date

Sep 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Mar 1995

Primary Completion Date

Not provided

Completion Date

Mar 1999

First Submitted Date

Sep 19, 2006

First Submission Date that Met QC Criteria

Sep 19, 2006

First Posted Date

Sep 20, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 19, 2006

Last Update Posted Date

Sep 20, 2006Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Finnish Institute for Health and WelfareOTHER_GOV

Collaborators

Name	Class
Merck Sharp & Dohme LLC	INDUSTRY
Wyeth-Lederle Vaccines	INDUSTRY
Pasteur Merieux Connaught	INDUSTRY

Description Module

Brief Summary

This was a randomized, double-blinded multicenter cohort study of Finnish children aged 2 to 24 months. The study was designed to evaluate the efficacy of two 7-valent pneumococcal conjugate vaccines (PncCRM and PncOMPC) parallelly, both vaccines compared with the same control vaccine (hepatitis B vaccine).

The primary endpoint was culture-confirmed pneumococcal acute otitis media (AOM) episodes due to all serotypes included in the pneumococcal conjugate vaccine and the primary hypothesis was that, compared to the control vaccine group, the pneumococcal conjugate vaccine would protect infants from culture confirmed AOM caused by pneumococcal serotypes in the vaccine. The efficacy of the two vaccines against any pneumococcal AOM and any AOM was also evaluated.

The children were vaccinated with the pneumococcal conjugate vaccine or the control vaccine at the age of 2, 4, 6 and 12 months and followed at study clinics established specifically for the purpose from 2 to 24 months of age. Whenever AOM was diagnosed during the follow-up, middle ear fluid was aspirated for bacterial culture.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

3,075

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Culture-confirmed pneumococcal acute otitis media episodes due to all serotypes included in the pneumococcal conjugate vaccine

Secondary Outcomes

Measure	Description	Time Frame
First episodes of culture-confirmed pneumococcal AOM due to all serotypes included in the pneumococcal conjugate vaccine

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

infants coming to their own child health center before the age of 13 weeks, and judged to be in good health on the basis of medical history and physical examination
family living permanently in Tampere, Kangasala or Nokia
at least one of the parents/guardians is able to communicate fluently in Finnish
written informed consent obtained from a parent/guardian prior to enrollment in the study

Exclusion Criteria:

hypersensitivity to any of the components of the vaccines used in the study,
known or suspected impairment of immunologic function,
history of invasive pneumococcal disease,
prior vaccination with any pneumococcal vaccine,
prior vaccination with hepatitis B vaccine,
contraindications to routine childhood immunizations
any medical condition in which, in the opinion of the investigator, the study procedures or vaccinations might cause risk to the health or endanger the well-being of the child

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Weeks

Maximum Age

12 Weeks

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Juhani Eskola, MD	Finnish Institute for Health and Welfare	Principal Investigator
Terhi Kilpi, MD	Finnish Institute for Health and Welfare	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kangasala Study Clinic		Kangasala		36200	Finland
Nokia Study Clinic

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
11172176	Result	Eskola J, Kilpi T, Palmu A, Jokinen J, Haapakoski J, Herva E, Takala A, Kayhty H, Karma P, Kohberger R, Siber G, Makela PH; Finnish Otitis Media Study Group. Efficacy of a pneumococcal conjugate vaccine against acute otitis media. N Engl J Med. 2001 Feb 8;344(6):403-9. doi: 10.1056/NEJM200102083440602.
14557958	Result

Name	Type	Description	Arm Group Labels	Other Names
7-valent pneumococcal-CRM197 conjugate vaccine	Biological
7-valent pneumococcal-OMPC conjugate vaccine	Biological

ID	Term
D010033	Otitis Media
D011008	Pneumococcal Infections

ID	Term
D010031	Otitis
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases
D013290	Streptococcal Infections
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections