Phase 4
Completed N=154
Immunogenicity and Safety Study of Fluarix™ Vaccine in Children Who Have Previously Been Vaccinated With Pandemrix™
Source: ClinicalTrials.gov NCT01196026 ↗Enrolled (actual)
154
Serious AEs
1.3%
Results posted
Jun 2012
Primary outcomePrimary: Haemagglutination Inhibition (HI) Antibody Titers Against H1N1 in All Subjects Receiving Fluarix Vaccine — 120.7; 1079.3 titer
Summary
This study is designed to assess the immunogenicity, reactogenicity and safety following vaccination with GSK Biologicals' Fluarix vaccine in children who have previously been vaccinated with two doses of Pandemrix at the age of 6 months-9 years.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Haemagglutination Inhibition (HI) Antibody Titers Against H1N1 in All Subjects Receiving Fluarix Vaccine |
120.7; 1079.3 | — |
| PRIMARY Number of Subjects Seropositive for HI Antibodies Against H1N1 in All Subjects Receiving Fluarix Vaccine |
65; 65 | — |
| PRIMARY Number of Subjects Seroprotected for HI Antibodies Against H1N1 in All Subjects Receiving Fluarix Vaccine |
63; 65 | — |
| PRIMARY Number of Subjects Seroconverted for HI Antibodies Against H1N1 in All Subjects Receiving Fluarix Vaccine |
55 | — |
| PRIMARY Mean Geometric Increase (MGI) in HI Antibody Titers Against H1N1 in All Subjects Receiving Fluarix Vaccine |
8.9 | — |
| SECONDARY HI Antibody Titers Against All Fluarix Vaccine Strains |
176.6; 124.9; 102.0; 171.4; 186.5; 105.3 | — |
| SECONDARY HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine |
201.6; 126.4; 96.9; 172.8; 195.6; 100.3 | — |
| SECONDARY Number of Subjects Seropositive for HI Antibodies Against All Fluarix Vaccine Strains |
7; 35; 23; 10; 43; 24 | — |
| SECONDARY Number of Subjects Seropositive for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine |
6; 28; 22; 9; 38; 23 | — |
| SECONDARY Number of Subjects Seroconverted for HI Antibodies Against All Fluarix Vaccine Strains in All Subjects Receiving Fluarix Vaccine |
5; 31; 19; 55; 7; 30 | — |
| SECONDARY Number of Subjects Seroconverted for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine |
5; 18; 12; 0; 1; 0 | — |
| SECONDARY Number of Subjects Seroprotected for HI Antibodies Against All Fluarix Vaccine Strains |
7; 33; 23; 10; 43; 24 | — |
| SECONDARY Number of Subjects Seroprotected for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine |
6; 26; 22; 9; 38; 23 | — |
| SECONDARY Mean Geometric Increase (MGI) in HI Antibody Titers Against All Fluarix Vaccine Strains in All Subjects Receiving Fluarix Vaccine |
10.2; 10.8; 6.5; 8.9; 10.8; 9.4 | — |
| SECONDARY Mean Geometric Increase (MGI) in HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine |
7.1; 4.5; 3.5; 0.5; 0.9; 0.7 | — |
| SECONDARY Serum Neutralising Antibody Titers Against All Fluarix Vaccine Strains |
359.1; 235.4; 237.6; 247.3; 5706.2; 5860.4 | — |
| SECONDARY Serum Neutralising Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine |
419.1; 254.8; 221.2; 292.0; 441.3; 212.8 | — |
| SECONDARY Number of Subjects Seropositive for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains |
7; 34; 23; 64; 7; 34 | — |
| SECONDARY Number of Subjects Seropositive for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine |
6; 27; 22; 9; 38; 23 | — |
| SECONDARY Number of Subjects Seroconverted for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains in Subjects Receiving Fluarix |
6; 33; 17; 56; 3; 11 | — |
| SECONDARY Number of Subjects Seroconverted for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine |
5; 22; 10; 0; 2; 0 | — |
| SECONDARY Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms |
3; 28; 21; 5; 19; 14 | — |
| SECONDARY Duration of Any Solicited Local Symptom |
1.0; 2.0; 2.0; 1.0; 1.0; 2.0 | — |
| SECONDARY Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms |
5; 8; 2; 2; 7; 0 | — |
| SECONDARY Duration of Any Solicited General Symptom Experienced by Subjects Less Than 6 Years Old |
2.0; 2.0; 1.0; 3.5; 1.0; 1.5 | — |
| SECONDARY Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Duration of Any Solicited General Symptom Experienced by Subjects Above 6 Years Old |
1.5; 1.0; 4.0; NA; 2.0; 1.0 | — |
| SECONDARY Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) |
6; 20; 7; 3; 15; 7 | — |
| SECONDARY Number of Subjects Reporting Medically-Attended Events (MAEs), Adverse Events of Specific Interest (AESIs)/ Potential Immune Mediated Diseases (pIMDs) and Adverse Events (AEs) of Special Interest |
4; 11; 2; 3; 7; 1 | — |
| SECONDARY Number of Subjects Reporting Serious Adverse Events (SAEs) |
1; 1; 0; 0; 0; 0 | — |
| SECONDARY Number of Subjects Reporting Serious Adverse Events (SAEs) |
1; 1; 0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects having previously been immunized with two 0.25 mL doses of Pandemrix, given at least 21 days apart, at the age of 6 months to 9 years inclusive at the time of first vaccination.
- Subjects having received the last dose of Pandemrix at least six months prior to study enrolment.
- Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol.
- Written informed consent obtained from the parent(s)/LAR(s) of the subjects.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Parent/LAR with access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user device.
Exclusion Criteria
- Active participation in other clinical trials.
- Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period.
- Planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration.
- Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to enrolment in this study or planned administration during the study period.
- Acute disease and/or fever at the time of enrolment.
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
- Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination.
- Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned use during the study.
- Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to any constituent of influenza vaccines; or a history of severe adverse reaction to a previous influenza vaccine.
- History of seizures or progressive neurological disease.
- Subjects having received an H1N1v pandemic vaccine other than Pandemrix or having received the 2010/2011 seasonal influenza vaccine.
- Child in care.
Data sourced from ClinicalTrials.gov (NCT01196026). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.