Clinical trial NCT00378417: Efficacy Trial of Two Pneumococcal Conjugate Vaccines (PncCRM and PncOMPC) for Prevention of Acute Otitis Media Due to Vaccine Serotypes
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Otitis Media
Pneumococcal Infections
Keywords: Otitis Media
Pneumococcal Infections
Pneumococcal Vaccines
Proportional Hazards Models
Prospective Studies
Streptococcus pneumoniae
Vaccines, Conjugate
Lead sponsor: Finnish Institute for Health and Welfare
Sponsor class: OTHER_GOV
Collaborators: name: Merck Sharp & Dohme LLC
name: Wyeth-Lederle Vaccines
name: Pasteur Merieux Connaught
First posted: 2006-09-20
Enrollment: 3075
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Culture-confirmed pneumococcal acute otitis media episodes due to all serotypes included in the pneumococcal conjugate vaccine
Secondary outcomes:
measure: First episodes of culture-confirmed pneumococcal AOM due to all serotypes included in the pneumococcal conjugate vaccine
Other outcomes:
Locations:
city: Kangasala
country: Finland
facility: Kangasala Study Clinic
city: Nokia
country: Finland
facility: Nokia Study Clinic
city: Tampere
country: Finland
facility: Eteläinen, Keskinen, and Läntinen Study Clinic
city: Tampere
country: Finland
facility: Itäinen and Pohjoinen Study Clinic
city: Tampere
country: Finland
facility: Kaakkoinen Study Clinic
Study officials:
affiliation: Finnish Institute for Health and Welfare
name: Juhani Eskola, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Finnish Institute for Health and Welfare
name: Terhi Kilpi, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.