Impact on Carriage, Acute Otitis Media, Immuno & Safety of GSK Biologicals' Pneumococcal Conjugate Vaccine 1024850A
NCT ID: NCT00839254
Last Updated: 2020-12-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
6181 participants
INTERVENTIONAL
2009-02-18
2012-01-31
Brief Summary
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The study will also assess the immune response to the GSK1024850A vaccine and the impact of the vaccine on occurrence of acute otitis media, carriage, safety in children starting vaccination below 18 months of age.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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10Pn3+1-6W-6M/053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.
Pneumococcal conjugate vaccine Synflorix (GSK1024850A)
2, 3 or 4 Intramuscular injections, depending on the age at the time of first vaccination
10Pn2+1-6W-6M/053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.
Pneumococcal conjugate vaccine Synflorix (GSK1024850A)
2, 3 or 4 Intramuscular injections, depending on the age at the time of first vaccination
Ctrl3+1-6W-6M/053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.
GSK Biologicals' Engerix TM vaccine (Hepatitis B vaccine)
3 or 4 Intramuscular injections, depending on the age at the time of first vaccination only for children \< 12 months of age at the time of first study vaccination.
Ctrl2+1-6W-6M/053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.
GSK Biologicals' Engerix TM vaccine (Hepatitis B vaccine)
3 or 4 Intramuscular injections, depending on the age at the time of first vaccination only for children \< 12 months of age at the time of first study vaccination.
10Pn7-11M/053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
Pneumococcal conjugate vaccine Synflorix (GSK1024850A)
2, 3 or 4 Intramuscular injections, depending on the age at the time of first vaccination
Ctrl7-11M/053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
GSK Biologicals' Engerix TM vaccine (Hepatitis B vaccine)
3 or 4 Intramuscular injections, depending on the age at the time of first vaccination only for children \< 12 months of age at the time of first study vaccination.
10Pn12-18M/053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
Pneumococcal conjugate vaccine Synflorix (GSK1024850A)
2, 3 or 4 Intramuscular injections, depending on the age at the time of first vaccination
Ctrl12-18M/053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
GSK Biologicals' Havrix TM vaccine (Hepatitis A vaccine)
2 Intramuscular injections only for children \>= 12 months of age at the time of first study vaccination.
Interventions
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Pneumococcal conjugate vaccine Synflorix (GSK1024850A)
2, 3 or 4 Intramuscular injections, depending on the age at the time of first vaccination
GSK Biologicals' Engerix TM vaccine (Hepatitis B vaccine)
3 or 4 Intramuscular injections, depending on the age at the time of first vaccination only for children \< 12 months of age at the time of first study vaccination.
GSK Biologicals' Havrix TM vaccine (Hepatitis A vaccine)
2 Intramuscular injections only for children \>= 12 months of age at the time of first study vaccination.
Eligibility Criteria
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Inclusion Criteria
* Male or female between, and including, 6 weeks to 18 months of age at the time of the first vaccination.
* Written informed consent obtained from parent(s) or from the guardian(s) of the subject.
Exclusion Criteria
* Previous vaccination with any registered, non-registered or investigational pneumococcal vaccine, or planned use of such a vaccine other than the study vaccine during the study period. If a child belongs to a high risk group for pneumococcal infections (such as children with an anatomic or functional asplenia, HIV infection, chronic cardiac or respiratory disease (not asthma), diabetes, cochlear implant, CSF fistula or with significant immunodeficiency) for which a licensed pneumococcal conjugate vaccine is made locally available, the subject can not be enrolled in the study and should be referred to the specific immunization program.
* Previous vaccination against Hepatitis B virus with any registered, non-registered or investigational vaccine, or planned use of such a vaccine other than the study vaccine during the study period.
* Previous vaccination against Hepatitis A virus with any registered, non-registered or investigational vaccine, or planned use of such a vaccine other than the study vaccine during the study period.
* Known severe hypersensitivity to any component of the study vaccines, including neomycin.
* Any medical condition that would contraindicate the initiation of routine immunization outside a clinical trial context.
6 Weeks
18 Months
ALL
Yes
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Espoo, , Finland
GSK Investigational Site
Helsinki, , Finland
GSK Investigational Site
Helsinki, , Finland
GSK Investigational Site
Järvenpää, , Finland
GSK Investigational Site
Kokkola, , Finland
GSK Investigational Site
Kotka, , Finland
GSK Investigational Site
Kuopio, , Finland
GSK Investigational Site
Lahti, , Finland
GSK Investigational Site
Oulu, , Finland
GSK Investigational Site
Pori, , Finland
GSK Investigational Site
Seinäjoki, , Finland
GSK Investigational Site
Tampere, , Finland
GSK Investigational Site
Turku, , Finland
GSK Investigational Site
Vantaa, , Finland
GSK Investigational Site
Vantaa, , Finland
Countries
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References
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Vesikari T, Forsten A, Seppa I, Kaijalainen T, Puumalainen T, Soininen A, Traskine M, Lommel P, Schoonbroodt S, Hezareh M, Moreira M, Borys D, Schuerman L. Effectiveness of the 10-Valent Pneumococcal Nontypeable Haemophilus influenzae Protein D-Conjugated Vaccine (PHiD-CV) Against Carriage and Acute Otitis Media-A Double-Blind Randomized Clinical Trial in Finland. J Pediatric Infect Dis Soc. 2016 Sep;5(3):237-248. doi: 10.1093/jpids/piw010. Epub 2016 Apr 28.
Rinta-Kokko H, Palmu AA, Ruokokoski E, Nieminen H, Moreira M, Schuerman L, Borys D, Jokinen J. Evaluation of the indirect impact of the 10-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine in a cluster-randomised trial. PLoS One. 2022 Jan 5;17(1):e0261750. doi: 10.1371/journal.pone.0261750. eCollection 2022.
Nieminen H, Rinta-Kokko H, Jokinen J, Puumalainen T, Moreira M, Borys D, Schuerman L, Palmu AA. Effectiveness of the 10-valent pneumococcal conjugate vaccine among girls, boys, preterm and low-birth-weight infants - Results from a randomized, double-blind vaccine trial. Vaccine. 2019 Jun 19;37(28):3715-3721. doi: 10.1016/j.vaccine.2019.05.033. Epub 2019 May 20.
Kilpi TM, Jokinen J, Puumalainen T, Nieminen H, Ruokokoski E, Rinta-Kokko H, Traskine M, Lommel P, Moreira M, Ruiz-Guinazu J, Borys D, Schuerman L, Palmu AA. Effectiveness of pneumococcal Haemophilus influenzae protein D conjugate vaccine against pneumonia in children: A cluster-randomised trial. Vaccine. 2018 Sep 18;36(39):5891-5901. doi: 10.1016/j.vaccine.2018.08.020. Epub 2018 Aug 23.
Palmu AA, Jokinen J, Nieminen H, Rinta-Kokko H, Ruokokoski E, Puumalainen T, Moreira M, Schuerman L, Borys D, Kilpi TM. Vaccine-preventable disease incidence of pneumococcal conjugate vaccine in the Finnish invasive pneumococcal disease vaccine trial. Vaccine. 2018 Mar 27;36(14):1816-1822. doi: 10.1016/j.vaccine.2018.02.088.
Palmu AA, Jokinen J, Nieminen H, Rinta-Kokko H, Ruokokoski E, Puumalainen T, Traskine M, Moreira M, Borys D, Schuerman L, Kilpi TM. Effectiveness of the Ten-valent Pneumococcal Conjugate Vaccine Against Tympanostomy Tube Placements in a Cluster-randomized Trial. Pediatr Infect Dis J. 2015 Nov;34(11):1230-5. doi: 10.1097/INF.0000000000000857.
Palmu AA, Jokinen J, Nieminen H, Syrjanen R, Ruokokoski E, Puumalainen T, Moreira M, Schuerman L, Borys D, Kilpi TM. Vaccine effectiveness of the pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10) against clinically suspected invasive pneumococcal disease: a cluster-randomised trial. Lancet Respir Med. 2014 Sep;2(9):717-27. doi: 10.1016/S2213-2600(14)70139-0. Epub 2014 Aug 7.
Palmu AA, Jokinen J, Nieminen H, Rinta-Kokko H, Ruokokoski E, Puumalainen T, Borys D, Lommel P, Traskine M, Moreira M, Schuerman L, Kilpi TM. Effect of pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10) on outpatient antimicrobial purchases: a double-blind, cluster randomised phase 3-4 trial. Lancet Infect Dis. 2014 Mar;14(3):205-12. doi: 10.1016/S1473-3099(13)70338-4. Epub 2013 Nov 26.
Palmu AA, Jokinen J, Borys D, Nieminen H, Ruokokoski E, Siira L, Puumalainen T, Lommel P, Hezareh M, Moreira M, Schuerman L, Kilpi TM. Effectiveness of the ten-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10) against invasive pneumococcal disease: a cluster randomised trial. Lancet. 2013 Jan 19;381(9862):214-22. doi: 10.1016/S0140-6736(12)61854-6. Epub 2012 Nov 16.
Other Identifiers
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2008-006551-51
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
112595
Identifier Type: -
Identifier Source: org_study_id
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