Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Havrix Junior · 1 trial · 1 indication
Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.
Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.
| Arm | Type | Description |
|---|---|---|
| D-QIV | EXPERIMENTAL | Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A). |
| Control | ACTIVE_COMPARATOR | In function of their age and D-QIV-vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®). |
| Name | Type | Description |
|---|---|---|
| Quadrivalent seasonal influenza vaccine(Flu D-QIV) GSK2321138A | BIOLOGICAL | Intramuscular injection |
| Havrix Junior | BIOLOGICAL | Intramuscular injection administered to subjects aged 12 months or older |
| Prevenar 13 | BIOLOGICAL | Intramuscular injection administered to subjects less than 12 months of age |
| Varivax/ProVarivax | BIOLOGICAL | Intramuscular injection administered to subjects more than 12 months of age |
| Varilrix | BIOLOGICAL | Subcutaneous injection administered to subjects more than 12 months of age |
Inclusion Criteria: * Subjects who the investigator believes that their parents/Legally Acceptable Representative (LARs) can and will comply with the requirements of the protocol. * A male or female between, and including, 6 and 35 months of age at the time of first vaccination; children are eligib...
Havrix Junior is an investigational vaccine being studied for the prevention of influenza in children. It is currently in Phase 3 clinical development and has not been approved by regulatory authorities. The drug is being evaluated for its efficacy in a pediatric population.
Havrix Junior is being developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the vaccine's safety and efficacy in children.
Havrix Junior is in Phase 3 clinical development. It is an investigational vaccine and has not yet received regulatory approval. The Phase 3 trial has been completed, and the data will be used to support potential future regulatory submissions.
Havrix Junior has been studied in one completed Phase 3 clinical trial, identified as NCT01439360. This trial, titled 'An Efficacy Study of GlaxoSmithKline (GSK) Biologicals' Candidate Influenza Vaccine GSK2321138A in Children,' enrolled 12,046 participants across multiple countries.
Yes, Havrix Junior is also known as GSK2321138A. In the clinical trial NCT01439360, the vaccine is referred to as GSK2321138A. This alternative name is used in the study title and may appear in scientific literature and regulatory documents.