Efficacy Trial of Two Pneumococcal Conjugate Vaccines (PncCRM and PncOMPC) for Prevention of Acute Otitis Media Due to Vaccine Serotypes

Pneumococcal Infections Clinical Trial

Official title:

Efficacy Trial in Finnish Children of Two Pneumococcal Conjugate Vaccines (PncCRM and PncOMPC) for Prevention of Acute Otitis Media Due to Pneumococcal Serotypes in the Vaccines

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00378417
• Other study ID #: KTL69-0
• Secondary ID: PNC95KTL
• Status: Completed
• Phase: Phase 3
• First received: September 19, 2006
• Last updated: September 19, 2006
• Start date: March 1995
• Est. completion date: March 1999

Study information

• Verified date: September 2006
• Source: National Institute for Health and Welfare, Finland
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationFinland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3075
• Est. completion date: March 1999
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Weeks to 12 Weeks

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Otitis
• Otitis Media
• Pneumococcal Infections

Intervention

Biological:
• 7-valent pneumococcal-CRM197 conjugate vaccine

• 7-valent pneumococcal-OMPC conjugate vaccine

Locations

Country	Name	City	State
Finland	Kangasala Study Clinic	Kangasala
Finland	Nokia Study Clinic	Nokia
Finland	Eteläinen, Keskinen, and Läntinen Study Clinic	Tampere
Finland	Itäinen and Pohjoinen Study Clinic	Tampere
Finland	Kaakkoinen Study Clinic	Tampere

Sponsors (4)

Lead Sponsor	Collaborator
National Institute for Health and Welfare, Finland	Merck Sharp & Dohme Corp., Pasteur Merieux Connaught, Wyeth-Lederle Vaccines

Country where clinical trial is conducted

Finland, 

References & Publications (2)

Eskola J, Kilpi T, Palmu A, Jokinen J, Haapakoski J, Herva E, Takala A, Käyhty H, Karma P, Kohberger R, Siber G, Mäkelä PH; Finnish Otitis Media Study Group. Efficacy of a pneumococcal conjugate vaccine against acute otitis media. N Engl J Med. 2001 Feb 8 — View Citation

Kilpi T, Ahman H, Jokinen J, Lankinen KS, Palmu A, Savolainen H, Grönholm M, Leinonen M, Hovi T, Eskola J, Käyhty H, Bohidar N, Sadoff JC, Mäkelä PH; Finnish Otitis Media Study Group. Protective efficacy of a second pneumococcal conjugate vaccine against — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Culture-confirmed pneumococcal acute otitis media episodes due to all serotypes included in the pneumococcal conjugate vaccine
Secondary	First episodes of culture-confirmed pneumococcal AOM due to all serotypes included in the pneumococcal conjugate vaccine