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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00378417

Enrollment

3075

Registered

2006-09-20

Start date

1995-03-31

Completion date

1999-03-31

Last updated

2006-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Otitis Media, Pneumococcal Infections

Keywords

Otitis Media, Pneumococcal Infections, Pneumococcal Vaccines, Proportional Hazards Models, Prospective Studies, Streptococcus pneumoniae, Vaccines, Conjugate

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.

Interventions

BIOLOGICAL7-valent pneumococcal-CRM197 conjugate vaccine

BIOLOGICAL7-valent pneumococcal-OMPC conjugate vaccine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

6 Weeks to 12 Weeks

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026