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CompletedNCT00378417Updated Sep 20, 2006

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

A Phase 3 interventional study of 7-valent pneumococcal-CRM197 conjugate vaccine and 7-valent pneumococcal-OMPC conjugate vaccine in Otitis Media and Pneumococcal Infections, sponsored by Finnish Institute for Health and Welfare. Completed at 5 sites in Finland. Open to participants aged 6 Weeks to 12 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2006-09-20.

Sponsored by Finnish Institute for Health and Welfare · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
3,075
Allocation
Randomized
Ages
6 Weeks to 12 Weeks
Sex
All
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Study 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.

02

Conditions studied

  • Otitis Media
  • Pneumococcal Infections

Keywords

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

Pneumococcal Infections

281 studies on the registry are indexed under Pneumococcal Infections; 27 are open to participants now.

This study's enrollment of 3,075 is above the median of 379 across 230 interventional studies indexed under Pneumococcal Infections.

Browse Pneumococcal Infections studies →

Lead sponsor

Finnish Institute for Health and Welfare is the lead sponsor of 43 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
6 Weeks to 12 Weeks
Sexes eligible
All
Accepts 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

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
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Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
3,075 participants

Interventions

  • Biological7-valent pneumococcal-CRM197 conjugate vaccine
  • Biological7-valent pneumococcal-OMPC conjugate vaccine
06

What researchers measure

Primary outcomes

  1. Culture-confirmed pneumococcal acute otitis media episodes due to all serotypes included in the pneumococcal conjugate vaccine

Secondary outcomes

  1. First episodes of culture-confirmed pneumococcal AOM due to all serotypes included in the pneumococcal conjugate vaccine

07

Study locations

5 sites
  • Kangasala Study Clinic
    Kangasala, 36200, Finland
  • Nokia Study Clinic
    Nokia, 37101, Finland
  • Eteläinen, Keskinen, and Läntinen Study Clinic
    Tampere, 33200, Finland
  • Itäinen and Pohjoinen Study Clinic
    Tampere, 33500, Finland
  • Kaakkoinen Study Clinic
    Tampere, 33720, Finland
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References and documents

Publications

  • 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. PubMed 11172176 ↗
  • Kilpi T, Ahman H, Jokinen J, Lankinen KS, Palmu A, Savolainen H, Gronholm M, Leinonen M, Hovi T, Eskola J, Kayhty H, Bohidar N, Sadoff JC, Makela PH; Finnish Otitis Media Study Group. Protective efficacy of a second pneumococcal conjugate vaccine against pneumococcal acute otitis media in infants and children: randomized, controlled trial of a 7-valent pneumococcal polysaccharide-meningococcal outer membrane protein complex conjugate vaccine in 1666 children. Clin Infect Dis. 2003 Nov 1;37(9):1155-64. doi: 10.1086/378744. Epub 2003 Oct 7. PubMed 14557958 ↗
  • Ekstrom N, Ahman H, Palmu A, Gronholm S, Kilpi T, Kayhty H; FinOM Study Group. Concentration and high avidity of pneumococcal antibodies persist at least 4 years after immunization with pneumococcal conjugate vaccine in infancy. Clin Vaccine Immunol. 2013 Jul;20(7):1034-40. doi: 10.1128/CVI.00039-13. Epub 2013 May 8. PubMed 23658394 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 20, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00378417
Lead sponsor
Finnish Institute for Health and Welfare
Collaborators
Merck Sharp & Dohme LLC, Wyeth-Lederle Vaccines, Pasteur Merieux Connaught
First posted
Sep 20, 2006
Start date
Mar 1995
Completion
Mar 1999
Last update
Sep 20, 2006

Study contacts

Juhani Eskola, MD
principal investigator · Finnish Institute for Health and Welfare
Terhi Kilpi, MD
study director · Finnish Institute for Health and Welfare
View the source record on ClinicalTrials.gov ↗

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