Booster Vaccination Study With a Pneumococcal Vaccine in... | NCT00911144

NCT00911144

Status Module

Sponsor/Collaborators Module

Oversight Module

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No data is available for this block.

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Synflorix Group	Experimental	Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.	Biological: GSK Biologicals' Synflorix™ (Pneumococcal vaccine GSK1024850A) Biological: GSK Biologicals' Hiberix™
Prevenar Group	Active Comparator	Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.	Biological: Wyeth-Lederle's Prevenar™ Biological: GSK Biologicals' Hiberix™

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GSK Biologicals' Synflorix™ (Pneumococcal vaccine GSK1024850A)	Biological	Intramuscular injection, administered as a single dose	Synflorix Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Subjects Reporting Grade 3 Adverse Events	Grade 3 adverse events are severe symptoms that prevent normal, everyday activities.	Within 31 days (Day 0 - Day 30) after booster vaccination.

Secondary Outcomes

Measure	Description	Time Frame
Number of Subjects Reporting Solicited Symptoms	Solicited local symptoms assessed include pain, redness and swelling at the injection site. Solicited general symptoms assessed include drowsiness, fever (equal to or above 37.5 degrees Celsius), irritability and loss of appetite.	Within 4 days (Days 0 to 3) after booster vaccination

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

A male or female between, and including, 12-18 months of age at the time of booster vaccination.
Subjects for whom the investigator believes that their parent(s)/ guardian(s) can and will comply with the requirements of the protocol.
Subjects who received three doses of pneumococcal conjugate vaccine in study NCT00680914.
Written informed consent obtained from the parent(s)/guardian(s) of the child/ward.
Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the vaccination, or planned use during the study period.
Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to vaccination.
Administration of immunoglobulins and/or any blood products within three months preceding the vaccination or planned administration during the study period.
Administration of any pneumococcal and/or Hib vaccine since the end of study NCT00680914.
Planned administration/administration of a vaccine not allowed by the study protocol during the period starting 1 month (30 days) before the administration of the booster dose of the study vaccines (Visit 1) and up to the follow-up visit (Visit 2) with the exception of vaccines included in the Korean routine immunization which can be given at least one week before the administration of the study vaccines or after study end.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
History of reactions or allergic disease likely to be exacerbated by any component of the study vaccines.
Known hypersensitivity to any component of the study vaccines including anaphylactic reactions following the administration of the study vaccines.
Major congenital defects or serious chronic illness.
History of any neurologic disorders or seizures.
Tympanic or axillary/ oral temperature >= 37.5°C or rectal temperature >= 38.0°C. A temperature greater than or equal to these cut-offs warrants deferral of the vaccination pending recovery of the subject.
Acute disease at the time of enrolment.

Contacts/Locations Module

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Ansan		425-707	South Korea
GSK Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation
21817957	Background	Kim CH, Kim JS, Cha SH, Kim KN, Kim JD, Lee KY, Kim HM, Kim JH, Hyuk S, Hong JY, Park SE, Kim YK, Kim NH, Fanic A, Borys D, Ruiz-Guinazu J, Moreira M, Schuerman L, Kim KH. Response to primary and booster vaccination with 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine in Korean infants. Pediatr Infect Dis J. 2011 Dec;30(12):e235-43. doi: 10.1097/INF.0b013e31822a8541.
	Background	Kim CH et al. Immunogenicity and safety of 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Korean children. Abstract presented at the Korean Society of Pediatric Infectious Diseases - 2011 Spring Conference. Seoul, South Korea, 7-11 June 2011.
	Background	Kim JS et al. Safety and reactogenicity of booster vaccination with 10-valent pneumococcal non-typeable Haemophilus influenzae protein d conjugate vaccine (PHiD-CV) in Korean children. Abstract presented at the 8th International Symposium on Antimicrobial Agents and Resistance (ISAAR). Seoul, Republic of Korea, 6-8 April 2011.

Label	URL
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.	View source

ID	Type	URL	Comment
112933	Informed Consent Form	View IPD

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Synflorix Group	Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

Pneumococcal vaccine GSK1024850A

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Synflorix Group	Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
BG001	Prevenar Group	Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

months

Title

Denominators

Categories

Title	Measurements
	OG00042 OG00113

Secondary

Number of Subjects Reporting Solicited Symptoms

Solicited local symptoms assessed include pain, redness and swelling at the injection site. Solicited general symptoms assessed include drowsiness, fever (equal to or above 37.5 degrees Celsius), irritability and loss of appetite.

Analysis was performed on the Total vaccinated cohort on the subjects with available data.

Posted

Count of Participants

Participants

Within 4 days (Days 0 to 3) after booster vaccination

ID	Title	Description
OG000	Synflorix Group	Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
OG001	Prevenar Group	Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.

Units	Counts
Participants

Secondary

Number of Subjects Reporting Unsolicited Adverse Events

An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study. Also any "solicited" symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.

Posted

Count of Participants

Participants

Within 31 days (Days 0 to 30) after booster vaccination

ID	Title	Description
OG000	Synflorix Group	Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
OG001	Prevenar Group	Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.

Units	Counts

Secondary

Number of Subjects Reporting Serious Adverse Events

Serious adverse events are medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.

Posted

Count of Participants

Participants

After booster vaccination up to study end (Month 0 to Month 1)

ID	Title	Description
OG000	Synflorix Group	Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
OG001	Prevenar Group	Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.

Units	Counts
Participants

Secondary

Concentration of Antibodies Against Vaccine Pneumococcal Serotypes

Concentrations of antibodies are measured by 22F-inhibition enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations expressed as microgram per milliliter (ug/mL).

Vaccine pneumococcal serotypes included serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.

Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data were available for antibodies against at least one study vaccine antigen after booster vaccination.

Posted

Geometric Mean

95% Confidence Interval

ug/mL

One month after booster vaccination (Month 1)

ID	Title	Description
OG000	Synflorix Group	Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
OG001	Prevenar Group	Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.

Secondary

Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes

Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line. The results are presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions.

Vaccine pneumococcal serotypes included serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.

Posted

Geometric Mean

95% Confidence Interval

titer

One month after booster vaccination (Month 1)

ID	Title	Description
OG000	Synflorix Group	Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
OG001	Prevenar Group	Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.

Secondary

Concentration of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A

Concentrations of antibodies are measured by 22F-inhibition ELISA and are presented as geometric mean concentrations expressed as microgram per milliliter.

Posted

Geometric Mean

95% Confidence Interval

ug/mL

One month after booster vaccination (Month 1)

ID	Title	Description
OG000	Synflorix Group	Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
OG001	Prevenar Group	Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.

Units

Secondary

Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A

Posted

Geometric Mean

95% Confidence Interval

titer

One month after booster vaccination (Month 1)

ID	Title	Description
OG000	Synflorix Group	Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
OG001	Prevenar Group	Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.

Secondary

Concentration of Antibodies Against Protein D (PD)

Concentrations of antibodies are presented as geometric mean concentrations expressed as Enzyme-Linked Immuno-Sorbent Assay (ELISA) units per milliliter (EU/mL).

Posted

Geometric Mean

95% Confidence Interval

EU/mL

One month after booster vaccination (Month 1)

ID	Title	Description
OG000	Synflorix Group	Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
OG001	Prevenar Group	Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.

Units	Counts

Secondary

Concentration of Antibodies Against Polyribosyl-ribitol-phosphate (PRP)

Concentrations of antibodies are presented as geometric mean concentrations expressed as microgram per milliliter.

Posted

Geometric Mean

95% Confidence Interval

ug/mL

One month after booster vaccination (Month 1)

ID	Title	Description
OG000	Synflorix Group	Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
OG001	Prevenar Group	Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.

Units	Counts

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Synflorix Group	Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.			8	335	243	335
EG001	Prevenar Group	Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.			4	113	82	113

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Pharyngitis	Infections and infestations	Non-systematic Assessment	EG0000 affected335 at risk EG0012 affected113 at risk
Pharyngotonsillitis	Infections and infestations	Non-systematic Assessment	EG0001 affected335 at risk EG0011 affected113 at risk
Pneumonia	Infections and infestations	Non-systematic Assessment	EG0002 affected335 at risk EG0010 affected113 at risk
Bronchopneumonia	Infections and infestations	Non-systematic Assessment	EG0000 affected335 at risk EG0011 affected113 at risk
Febrile convulsion	Nervous system disorders	Non-systematic Assessment	EG0001 affected335 at risk EG0010 affected113 at risk
Gastroenteritis rotavirus	Infections and infestations	Non-systematic Assessment	EG0001 affected335 at risk EG0010 affected113 at risk
H1N1 influenza	Infections and infestations	Non-systematic Assessment	EG0001 affected335 at risk EG0010 affected113 at risk
Hand-foot-and-mouth disease	Infections and infestations	Non-systematic Assessment	EG0001 affected335 at risk EG0010 affected113 at risk
Otitis media acute	Infections and infestations	Non-systematic Assessment	EG0001 affected335 at risk EG0010 affected113 at risk
Pyrexia	General disorders	Non-systematic Assessment	EG0000 affected335 at risk EG0011 affected113 at risk
Urticaria	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0001 affected335 at risk EG0010 affected113 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Upper respiratory tract infection	Infections and infestations	Non-systematic Assessment	EG00030 affected335 at risk EG00112 affected113 at risk
Nasopharyngitis	Infections and infestations	Non-systematic Assessment	EG00019 affected335 at risk EG00110 affected113 at risk
Pain at the injection site	General disorders	Systematic Assessment	EG000120 affected332 at risk EG00139 affected113 at risk
Redness at the injection site	General disorders	Systematic Assessment	EG000142 affected332 at risk EG00155 affected113 at risk
Swelling at the injection site	General disorders	Systematic Assessment	EG00097 affected332 at risk EG00135 affected113 at risk
Drowsiness	General disorders	Systematic Assessment	EG00075 affected332 at risk EG00121 affected113 at risk
Fever	General disorders	Systematic Assessment	EG00046 affected332 at risk EG00120 affected113 at risk
Irritability	General disorders	Systematic Assessment	EG000141 affected332 at risk EG00142 affected113 at risk
Loss of appetite	General disorders	Systematic Assessment	EG00071 affected332 at risk EG00129 affected113 at risk

ID	Term
D013290	Streptococcal Infections
D011008	Pneumococcal Infections

Units	Counts
Participants	OG000317 OG001102

Units	Counts
Participants	OG000151 OG00147

(17115.7 to 52298.1)

ID	Term
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections