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

NCT00378417 | Completed Phase 3

• 2 other identifiers: KTL69-0PNC95KTL
• Study Type: interventional
• Target: 3,075
• Locations: 1 country
• Sites: 5

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.

Conditions

Otitis Media; Pneumococcal Infections

Keywords

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

Outcome Measures

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

Interventions

7-valent pneumococcal-CRM197 conjugate vaccine BIOLOGICAL

7-valent pneumococcal-OMPC conjugate vaccine BIOLOGICAL

Eligibility Criteria

• Age: 6 Weeks - 12 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Finnish Institute for Health and Welfare: lead
• Merck Sharp & Dohme LLC: collaborator
• Wyeth-Lederle Vaccines: collaborator
• Pasteur Merieux Connaught: collaborator

Study Sites (5)

Kangasala Study Clinic

Kangasala, 36200, Finland

Location

Nokia Study Clinic

Nokia, 37101, Finland

Location

Eteläinen, Keskinen, and Läntinen Study Clinic

Tampere, 33200, Finland

Location

Itäinen and Pohjoinen Study Clinic

Tampere, 33500, Finland

Location

Kaakkoinen Study Clinic

Tampere, 33720, Finland

Location

Related Publications (3)

• 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.

  PMID: 11172176 RESULT

• 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.

  PMID: 14557958 RESULT

• 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.

  PMID: 23658394 DERIVED

MeSH Terms

Conditions

Otitis Media; Pneumococcal Infections

Condition Hierarchy (Ancestors)

Otitis; Ear Diseases; Otorhinolaryngologic Diseases; Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Juhani Eskola, MD

  Finnish Institute for Health and Welfare

  PRINCIPAL INVESTIGATOR

• Terhi Kilpi, MD

  Finnish Institute for Health and Welfare

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: September 19, 2006
• First Posted: September 20, 2006
• Study Start: March 1, 1995
• Study Completion: March 1, 1999
• Last Updated: September 20, 2006

Record last verified: 2006-09

Locations

FI (5)