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

Finnish Institute for Health and Welfare

Status and phase

Completed

Phase 3

Conditions

Otitis Media

Pneumococcal Infections

Treatments

Biological: 7-valent pneumococcal-OMPC conjugate vaccine

Biological: 7-valent pneumococcal-CRM197 conjugate vaccine

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00378417

PNC95KTL

KTL69-0

Details and patient eligibility

About

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.

Sex

All

Ages

6 to 12 weeks old

Volunteers

Accepts Healthy Volunteers

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