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Protocol Summaries: Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed)

GSK Study ID	Phase	Title	Status
105539	phase 3	An open, randomized, phase IIIa study to evaluate the safety and immunogenicity of GSK Biologicals' 10-valent pneumococcal conjugate vaccine, when administered intramuscularly according to a 2-4-11 months vaccination schedule	Completed
105553	phase 3	Assess lot-to-lot consistency of 3 lots (double blind design) of GSK Biologicals' 10-valent pneumococcal vaccine & evaluate non-inferiority to Prevenar™ (single blind design) when admnd as 3-dose pry immunization course before 6 mths of age	Completed
105554	phase 3	Phase IIIa randomized, controlled study to assess the immunogenicity of GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal conjugate vaccine, when administered as a 3-dose primary immunization course before 6 months of age	Completed
106068	phase 1	A study to compare the safety, reactogenicity & immunogenicity of GSK Biologicals pneumococcal vaccines vs the licensed 23-valent pneumococcal polysaccharide vaccine, in healthy elderly subjects	Completed
106623	phase 3	Multicentre immune memory study in healthy children following a 3 dose primary vaccination with Prevenar or GSK Biologicals' pneumococcal conjugate vaccine via the administration of a single booster dose of Pneumovax 23	Completed
107005	phase 3	To assess safety, reactogenicity and immunogenicity of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine, when co-administered with DTPa-combined vaccines and MenC or Hib-MenC vaccines during the first 6 months of age.	Completed
107007	phase 3	To assess the safety, reactogenicity and immunogenicity of GSK Bio pneumococcal conjugate vaccine compared to Prevenar™, co-admin with DTPw-HBV/Hib & OPV or IPV vaccines as a 3-dose primary immunization course during the first 6 mo of age	Completed
107046	phase 3	To assess the safety, reactogenicity & immunogenicity of a 4th dose of GSK Biologicals’ pneumococcal vaccine or Prevenar™ in children (12-18 mo) previously vaccinated in the primary study 105553 with either pneumococcal vaccine or Prevenar™	Completed
107058	phase 3	Evaluate immunogenicity, safety & reactogenicity of GSK Biologicals' 10-valent pneumococcal conjugate vaccine given as catch-up immunization in children older than 7 mo of age or as 3-dose primary immunization in children before 6 mo of age	Completed
107137	phase 3	Prophylactic antipyretic treatment in children receiving booster dose of pneumococcal vaccine GSK1024850A and DTPa-HBV-IPV/Hib vaccine (Infanrix hexa) and assessment of impact of pneumococcal vaccination on nasopharyngeal carriage	Completed
107706	phase 3	To assess safety, reactogenicity & immunogenicity of a booster dose of pneumococcal conjugate vaccine, co-admin with GSK Biologicals’ MMRV vaccine in children (2nd yr of life) primed with the pneumococcal conjugate vaccine in study 105553.	Completed
107737	phase 3	Study to assess the safety and immunogenicity of GSK Biologicals 10-valent pneumococcal conjugate vaccine when Co-administered with DTPa-HBV-IPV/Hib (Infanrix-Hexa) vaccine in preterm infants as a 3-dose primary immunization course during the first 6 months of life.	Completed
109509	phase 3	Booster vaccination course with the pneumococcal vaccine GSK 1024850A, DTPw-HBV/Hib and OPV or IPV in children who completed the primary vaccination course in study 107007	Completed
109563	phase 3	COMPAS: A phase III study to demonstrate efficacy of GSK Biologicals' 10-valent pneumococcal vaccine (GSK1024850A) against Community Acquired Pneumonia and Acute Otitis Media	Completed
109621	phase 3	Safety, reactogenicity and immunogenicity following booster dose of GSK Biologicals´ pneumococcal conjugate vaccine when co-administered with a booster dose of Infanrix-IPV/Hib in preterm born children at 16-18 months of age	Completed
109661	phase 3	Primary vaccination course in children receiving the pneumococcal vaccine GSK 1024850A, Infanrix hexa and Rotarix	Completed
110031	phase 2	Phase II, observer-blind follow-up study to assess reacto-and immunogenicity of GSK Biologicals' pneumococcal conjugate vaccine (GSK1024850A), when given as booster in primed children or as 2-dose catch-up in unprimed children.	Completed
110142	phase 3	Non-inferiority of co-administration of GSK Biologicals’pneumococcal conjugate vaccine GSK1024850A with DTPa-IPV-Hib versus co-administration with DTPa-HBV-IPV/Hib.	Completed
110521	phase 3	Primary vaccination course in children receiving the pneumococcal vaccine GSK 1024850A co-administered with Zilbrix™ Hib and Polio Sabin™	Completed
110808	phase 3	Primary vaccination course in children receiving the pneumococcal vaccine GSK 1024850A or Prevenar™ co-administered with Hiberix™	Completed
111188	phase 3	Primary vaccination course in healthy children receiving the pneumococcal vaccine GSK 1024850A co-administered with Tritanrix™-HepB/Hib at 6, 10 and 14 weeks of age	Completed
111337		Identification and Characterization of the Bacteria Causing Acute Otitis Media (AOM) Episodes in Young Children in Saudi Arabia	Completed
111339		Identification and characterization of the bacteria causing Acute Otitis Media (AOM) episodes in young children in Turkey	Withdrawn
111345 (Mth 12)	phase 3	Long-term follow-up study to assess antibody persistence in children previously vaccinated with four doses of pneumococcal conjugate vaccine in primary vaccination study (105553) and booster vaccination study (107046)	Completed
111442	phase 3	Evaluation of effectiveness of GSK Biologicals’ pneumococcal conjugate vaccine 1024850A against invasive disease	Active not recruiting
111634	phase 3	Primary and booster vaccination course in human immunodeficiency virus (HIV) infected infants, HIV exposed uninfected infants and unexposed uninfected infants receiving the pneumococcal vaccine GSK 1024850A.	Completed
111654	phase 3	Non-inferiority of a commercial lot of the pneumococcal vaccine GSK1024850A compared to a clinical lot.	Completed
111736	phase 3	Vaccination course in children primed and boosted with pneumococcal vaccine GSK 1024850A and in age-matched unprimed children	Completed
112595	phase 3	Impact on nasopharyngeal carriage, acute otitis media, immunogenicity and safety of GSK Biologicals’ pneumococcal conjugate vaccine 1024850A	Completed
112640	phase 3	Immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals’ pneumococcal vaccine 1024850A following primary and booster vaccination of healthy Japanese children	Completed
112801	phase 3	Vaccination course in children primed and boosted with pneumococcal vaccine GSK 1024850A and in age-matched unprimed children	Completed
112807	phase 3	Vaccination with the pneumococcal vaccine GSK 1024850A or Prevenar™ at approximately 4 years of age in children primed with 3 doses of GSK 1024850A vaccine or Prevenar™ and boosted with 23-valent pneumococcal plain polysaccharide vaccine	Completed
112909	phase 3	Booster vaccination with pneumococcal vaccine GSK1024850A in primed children and catch-up vaccination in unprimed children	Completed
112921	phase 4	Impact of immediate or delayed prophylactic antipyretic treatment on the immunogenicity, reactogenicity and safety of GlaxoSmithKline Biologicals’ pneumococcal vaccine 1024850A and the co-administered DTPa-combined vaccines	Completed
112933	phase 3	Booster vaccination with pneumococcal vaccine GSK1024850A or Prevenar™ co-administered with Hiberix™ in children primed with the same vaccines	Completed
112956	n\a	Identification and characterisation of bacteria causing chronic cough among children in the United Kingdom	Completed
113151	phase 3	Primary vaccination course with the pneumococcal vaccine GSK 1024850A, in healthy infants in Vietnam when co-administered with GSK Biologicals’ Infanrix hexa™ (DTPa-HBV-IPV/Hib) vaccine	Completed
113166	phase 3	Safety, reactogenicity and immunogenicity study of GSK Biologicals’ pneumococcal vaccine GSK1024850A, given either as a booster dose or as a 2-dose catch-up immunization in healthy Malian children	Completed
113199	phase 3	Safety, reactogenicity and immunogenicity study of GSK Biologicals’ pneumococcal vaccine GSK1024850A, given either as a booster dose or as a 2-dose catch-up immunization in healthy Nigerian children	Completed
113266	phase 3	Evaluation of immunological persistence following 3-dose priming with GSK Biologicals’ 10-valent pneumococcal conjugate vaccine in study NCT00808444 and safety and immunogenicity following a booster dose of the same vaccine	Completed
113381	phase 4	Post-marketing surveillance study of GSK Biologicals’ pneumococcal conjugate vaccine, Synflorix, when administered according to the local Prescribing Information in Philippines	Recruiting
113932		Identification and characterization of the bacteria causing Acute Otitis Media (AOM) episodes in young children in Taiwan	Terminated
114056	phase 3	Immunogenicity, safety and reactogenicity of GSK Biologicals’ pneumococcal vaccine 1024850A when administered to children between 8 weeks and 2 years of age	Completed
114174	phase 2	Impact of GSK Biologicals’ 2189242A vaccine on nasopharyngeal carriage, safety and immunogenicity when co-administered with routine EPI vaccines in infants following safety assessment in children aged 2-4 yrs in The Gambia	Completed
114469	phase 4	Safety of GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal-protein D-diphtheria toxoid-tetanus toxoid conjugate (10PN-PD-DiT) vaccine, Synflorix when administered according to the approved Prescribing Information in Korea	Recruiting
115356		To evaluate incidence of acute otitis media in children aged < 6 years in five East European countries	Completed
115373	phase 1	Safety and immunogenicity study of GSK Biologicals’ pneumococcal vaccine 2830930A when administered as a single dose in healthy toddlers aged 12-23 months	Completed
115884	phase 3	Immunogenicity, safety and reactogenicity study of GSK Biologicals’ pneumococcal vaccine (Synflorix™) when administered to children who are at an increased risk of pneumococcal infection	Not yet recruiting
115992	phase 3	Two-dose primary vaccination with either GSK Biologicals' 10-valent pneumococcal vaccine (Synflorix™) or Pfizer’s Prevenar 13™ or both vaccines followed by a booster dose of Synflorix™	Active not recruiting
116290	phase 4	Post-marketing surveillance (PMS) of GlaxoSmithKline Biologicals’ 10-valent pneumococcal conjugate vaccine (Synflorix™) when administered to healthy infants and children according to the Prescribing Information in Sri Lanka	Not yet recruiting