Otitis MediaPhase 3NCT00378417
Efficacy Trial of Two Pneumococcal Conjugate Vaccines (PncCRM and PncOMPC) for Prevention of Acute Otitis Media Due to Vaccine Serotypes
A Phase 3 study testing 7-valent pneumococcal-CRM197 conjugate vaccine and 7-valent pneumococcal-OMPC conjugate vaccine in people with Otitis Media and Pneumococcal Infections, run by Finnish Institute for Health and Welfare at 5 sites in Finland.
Trial 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). Read more about this study
- Who is it for?
- Ages 6 to 12 weeksHealthy volunteers can take part
- Conditions the study is for
- Otitis Media, Pneumococcal Infections
- What is being tested?
- 7-valent pneumococcal-CRM197 conjugate vaccine and 7-valent pneumococcal-OMPC conjugate vaccine
- Type of treatment
- Vaccines
- How many people
- 3,075 participants
- Where
- 5 sitesFinland
- Study dates
- Mar 1995to Mar 1999
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Finland5 sites
Kangasala Study Clinic
Kangasala, 36200
Nokia Study Clinic
Nokia, 37101
Eteläinen, Keskinen, and Läntinen Study Clinic
Tampere, 33200
Itäinen and Pohjoinen Study Clinic
Tampere, 33500
Kaakkoinen Study Clinic
Tampere, 33720
About this study
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
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
- Being tested
- 7-valent pneumococcal-CRM197 conjugate vaccine, 7-valent pneumococcal-OMPC conjugate vaccine
- Keywords
- Otitis Media, Pneumococcal Infections, Pneumococcal Vaccines, Proportional Hazards Models, Prospective Studies, Streptococcus pneumoniae, Vaccines, Conjugate
- Medical subject headings
- Otitis Media, Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7-valent pneumococcal-CRM197 conjugate vaccineBiological
7-valent pneumococcal-OMPC conjugate vaccineBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2006 (estimated)
- Study startMar 1995
- Study completionMar 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Otitis MediaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 3,075 participants
Sponsor and investigators
- Lead sponsor
- Finnish Institute for Health and Welfare
- Sponsor type
- Other government
- Collaborators
- Merck Sharp & Dohme LLC, Wyeth-Lederle Vaccines, Pasteur Merieux Connaught
- Investigators
- Juhani Eskola, MD, Principal investigator, Finnish Institute for Health and WelfareTerhi Kilpi, MD, Study director, Finnish Institute for Health and Welfare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00378417
- Sponsor's protocol ID
- KTL69-0
- Other IDs
- PNC95KTL
- Status last verified
- Sep 2006
- First submitted
- 19 Sep 2006
- Last updated
- 20 Sep 2006
- Results posted
- No
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 11172176Kilpi 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 14557958Ekstrom 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
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00378417
- Acronym / sponsor ID
- KTL69-0
- Conditions
- Otitis Media, Pneumococcal Infections
- Keywords
- Otitis Media, Pneumococcal Infections, Pneumococcal Vaccines, Proportional Hazards Models, Prospective Studies, Streptococcus pneumoniae, Vaccines, Conjugate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,075 participants
- Lead sponsor
- Finnish Institute for Health and WelfareOther government
- Collaborators
- Merck Sharp & Dohme LLC, Wyeth-Lederle Vaccines, Pasteur Merieux Connaught
- Study start
- Mar 1995
- Study completion
- Mar 1999
- First posted
- 20 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 6 to 12 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 7-valent pneumococcal-CRM197 conjugate vaccine | Biological | – |
| 7-valent pneumococcal-OMPC conjugate vaccine | Biological | – |
Primary outcome
Culture-confirmed pneumococcal acute otitis media episodes due to all serotypes included in the pneumococcal conjugate vaccine
1 secondary outcome
First episodes of culture-confirmed pneumococcal AOM due to all serotypes included in the pneumococcal conjugate vaccine
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2006.
- Results publication: PubMed 11172176Eskola 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.
- Results publication: PubMed 14557958Kilpi 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.
- Derived from this study: PubMed 23658394Ekstrom 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juhani Eskola, MD principal investigator
Finnish Institute for Health and Welfare
Terhi Kilpi, MD study director
Finnish Institute for Health and Welfare
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 7-valent pneumococcal-CRM197 conjugate vaccine and 7-valent pneumococcal-OMPC conjugate vaccine in people with Otitis Media and Pneumococcal Infections, run by Finnish Institute for Health and Welfare at 5 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Culture-confirmed pneumococcal acute otitis media episodes due to all serotypes included in the pneumococcal conjugate vaccine. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00378417, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2006.