CLINICAL TRIALS PROFILE FOR INFANRIX

All Clinical Trials for INFANRIX

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00370318 ↗	Prophylactic Antipyretic Treatment in Children Receiving Pneumococcal Conjugate and Standard Infant Vaccines	Completed	GlaxoSmithKline	Phase 3	2006-09-01	The purpose of this trial is to assess if the rate of febrile reactions following the co-administration of pneumococcal conjugate vaccines with standard infant vaccines is lowered when paracetamol is given prophylactically.
NCT00496015 ↗	Prophylactic Antipyretic Treatment in Children Receiving Booster Dose of Pneumococcal Conjugate Vaccine GSK1024850A	Completed	GlaxoSmithKline	Phase 3	2007-07-02	The purpose of this trial is to assess if the rate of febrile reactions following the co-administration of a booster dose of pneumococcal conjugate vaccines with standard infant vaccines is lowered when paracetamol is given prophylactically and to assess the impact of pneumococcal conjugate vaccine on pneumococcal and H. influenzae nasopharyngeal carriage compared to control group receiving meningococcal conjugate vaccine (GSK134612). This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00370318).
NCT01392378 ↗	Study Assessing the Effect of Medications to Prevent Fever on Prevenar 13®	Completed	Pfizer	Phase 4	2011-08-01	The purposes of this study are assess the immunological response (measure the amount of antibodies, i.e. proteins that fight off germs) produced by children after they have been given the 13-valent pneumococcal vaccine (13vPnC) and INFANRIX hexa at 2, 3, 4 and 12 months of age when medications to prevent fever are given on the same day as the vaccination. Also to evaluate the safety of 13-valent pneumococcal conjugate vaccine (13vPnC) in children who receive medications to prevent fever on the day of vaccination.
NCT02422264 ↗	Immunogenicity and Safety Study of Infanrix Hexa in Healthy Infants Born to Mothers Vaccinated With Boostrix™ During Pregnancy or Immediately Post-delivery	Completed	GlaxoSmithKline	Phase 4	2016-01-22	The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals' Infanrix hexa, given in the primary vaccination schedule to infants born to pregnant women who participated in study 116945 [DTPA (BOOSTRIX)-047]. This study will help us evaluate if the presence of transplacentally transferred maternal antibodies interfere with the immune response to primary vaccination with Infanrix hexa and a co-administered pneumococcal conjugate vaccine given as a part of this study in infants.
NCT05073003 ↗	A Study on the Safety and Immune Responses to the GVGH altSonflex1-2-3 Vaccine Against Shigellosis in Adults, Children, and Infants	Recruiting	GlaxoSmithKline	Phase 1/Phase 2	2021-10-06	The aim of the current clinical study is to evaluate, for the first time in humans (FTIH), the safety and immunogenicity of the altSonflex1-2-3 candidate vaccine against S. sonnei and S. flexneri serotypes 1b, 2a, and 3a. The vaccine will be first administered in adults 18 to 50 years of age in Europe. Subsequently, the vaccine will be administered to a shigellosis-endemic population in Africa, first in adults 18 to 50 years of age, then in children 24 to 59 months of age, and finally in infants 9 months of age. Infants will also receive a third vaccination. Three different doses of the vaccine [low (Dose A), medium (Dose B), and high (Dose C) amounts of antigen] will be evaluated using an age de-escalation approach (from least vulnerable adult population to most vulnerable paediatric population). The results of this study will allow the selection of the most appropriate dose for further vaccine development in infants 9 months of age, which is the main target age group for this vaccine.

Clinical Trial Conditions for INFANRIX

Condition Name

Condition Name for INFANRIX
Intervention	Trials
Diphtheria-Tetanus-aPertussis-Hepatitis B-Poliomyelitis-Haemophilus Influenzae Type b Vaccines	1
Infections, Rotavirus	1
Infections, Streptococcal	1
Pneumococcal Vaccines	1

Condition MeSH

Condition MeSH for INFANRIX
Intervention	Trials
Influenza, Human	1
Hepatitis B	1
Diarrhea	1
Hepatitis	1

Clinical Trial Locations for INFANRIX

Trials by Country

Trials by Country for INFANRIX
Location	Trials
Canada	3
Czech Republic	3
Czechia	2
Spain	2
Italy	2

Clinical Trial Progress for INFANRIX

Clinical Trial Phase

Clinical Trial Phase for INFANRIX
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	2
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for INFANRIX
Clinical Trial Phase	Trials
Completed	4
Recruiting	1

Clinical Trial Sponsors for INFANRIX

Sponsor Name

Sponsor Name for INFANRIX
Sponsor	Trials
GlaxoSmithKline	4
Pfizer	1

Sponsor Type

Sponsor Type for INFANRIX
Sponsor	Trials
Industry	5

INFANRIX: Clinical Trials Update, Market Analysis, and Revenue Projection

Last updated: May 2, 2026

What is INFANRIX and what does it cover commercially?

INFANRIX is a family of pediatric combination vaccines from GlaxoSmithKline (GSK) that protect against diphtheria, tetanus, and pertussis (DTaP), marketed as:

• INFANRIX (DTaP)
• INFANRIX-IPV / INFANRIX hexa (expanded formulations including polio and, in some geographies, other antigens such as hepatitis B and Hib)

Commercial framing for market work is anchored on WHO and country EPI schedules in which DTaP-containing vaccines form the core infant series, with recurring demand driven by birth cohort size, immunization coverage, and routine procurement cycles.

What is the latest clinical trial update for INFANRIX?

No complete, up-to-date clinical-trials status for INFANRIX (by formulation, trial identifier, and phase) is provided in the available source set in this session. Under the operating constraints, a complete and accurate trial update cannot be produced without trial-level identifiers and current registry status.

As a result, this report does not list trial findings, recruitment status, or regulatory milestones that would require verified sourcing.

What does the market look like for DTaP-containing vaccines and where does INFANRIX fit?

DTaP-based infant immunization is a mature, procurement-driven market with demand shaped by:

• Routine infant immunization schedules (multi-dose series)
• National tendering and panel contracting (often multi-year)
• Competitive pricing against other combination DTaP brands and local manufacturers
• Product switching tied to formulation needs (e.g., polio-only vs hexavalent)

INFANRIX competes in multi-antigen DTaP combinations with other GSK and non-GSK manufacturers depending on country tender structures.

How big is the addressable market and what is INFANRIX’s revenue logic?

A defensible revenue projection requires numeric baseline sales, mix by formulation, and procurement assumptions by geography. Those inputs require cited financial statements or market datasets. In the available source set in this session, those baseline figures are not provided.

Under the operating constraints, this report does not produce a quantified projection (USD or unit volumes) for INFANRIX.

What are the key demand drivers for INFANRIX over a forecast horizon?

Even without quantified revenue, the demand mechanics for DTaP combination vaccines are consistent across markets:

• Birth cohort growth or decline drives the top-line volume ceiling
• Immunization coverage drives utilization per eligible child
• Schedule adherence affects conversion from eligible to fully vaccinated
• Competitive tender outcomes determine share and ASP direction
• Vaccine availability and supply continuity affect missed procurement and catch-up

What are the main competitive and channel dynamics?

For infant combination vaccines, distribution is typically:

• Direct-to-government tender procurement or via national immunization programs
• Limited use of commercial retail channels
• Contracted distribution terms that can lock in pricing and volumes for periods

Competitive dynamics for INFANRIX are therefore less about brand pull and more about:

• Tender evaluation (price, supply reliability, cold-chain compliance)
• Formulation fit (DTaP only vs DTaP-IPV vs hexavalent)
• Local regulatory approvals and national program inclusion

How should portfolio strategy be evaluated for INFANRIX?

Business decisions for INFANRIX should be evaluated on:

• Formulation coverage across polio and multi-antigen combinations by geography
• Tender resilience: ability to win recurring multi-year contracts
• Supply and manufacturing throughput to avoid procurement failure risk
• Government pricing strategy to manage ASP pressure

Market projection framework (non-quantified)

A working forecast model for INFANRIX in DTaP combinations uses:

1. Eligible population (births or infants by schedule year)
2. Dose series completion rate
3. Formulation mix (DTaP vs DTaP-IPV vs hexavalent share)
4. Country-level share from tender awards
5. Net price after discounts, rebates, and program-specific pricing terms
6. Execution risk (supply constraints, lot releases, distribution interruptions)

A quantified projection cannot be stated without cited baseline sales, volumes, and net price data.

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Key Takeaways

• INFANRIX is a mature, procurement-driven DTaP combination vaccine family marketed by GSK for routine pediatric immunization.
• A complete, sourced clinical-trials update for INFANRIX cannot be produced from the available source set in this session.
• A quantified INFANRIX market projection cannot be produced without cited baseline sales, volumes, and pricing assumptions.
• Forecasting INFANRIX revenue is tied to birth cohort demand, immunization coverage, formulation mix, and recurring government tender outcomes.

FAQs

1. Is INFANRIX a single vaccine product or a vaccine family?
   It is marketed as a family of DTaP-containing pediatric combination vaccines with different antigen compositions by region and formulation.

2. Where does INFANRIX revenue come from?
   Primarily from government procurement for routine infant immunization programs rather than retail demand.

3. What determines INFANRIX demand in a country?
   Birth cohort size, immunization coverage, schedule adherence, and government tender participation and award outcomes.

4. What type of clinical development does a mature vaccine like INFANRIX typically see?
   Updated formulations, additional indication studies, and post-authorization evaluations, with development progress typically reflected through clinical trial registry entries and regulatory updates.

5. What inputs are required to produce a quantified revenue projection for INFANRIX?
   Baseline INFANRIX sales (by formulation and geography), unit volumes, net pricing, and an explicit set of procurement, mix, and share assumptions over the forecast horizon.

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References

[1] World Health Organization. WHO position papers and vaccine-related guidance for diphtheria-tetanus-pertussis immunization. WHO.
[2] GSK. Product information and portfolio materials for INFANRIX. GSK.