CLINICAL TRIALS PROFILE FOR BOOSTRIX

All Clinical Trials for BOOSTRIX

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02377349 ↗	Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Boostrix™ Vaccine in Pregnant Women	Completed	GlaxoSmithKline	Phase 4	2015-10-14	The purpose of this study is to assess the immunogenicity and safety of Boostrix™ when compared to a placebo given during 27-36 weeks of gestation in healthy women aged 18-45 years. Infants born to mothers enrolled in this study will be followed-up in two separate clinical studies: 201330 [DTPA (BOOSTRIX)-048 PRI] and 201334 [DTPA (BOOSTRIX)-049 BST: 048].
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.
NCT02526394 ↗	Pertussis and Meningitis C Concomitant Vaccination in Adolescents	Completed	Public Health England	Phase 4	2013-09-01	The trial includes groups receiving various combinations of meningitis C and pertussis containing vaccines, to be administered concomitantly in adolescents due their school leaving booster vaccinations (as per UK routine immunisation schedule at 13-17 years of age). Immunogenicity and reactogenicity will be assessed.
NCT04138056 ↗	A Study of a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone and Together With a Vaccine Against Diphtheria, Pertussis and Tetanus (Tdap) Viruses Followed by a 2nd Dose of the RSV Vaccine to Healthy Non-Pregnant Women	Active, not recruiting	GlaxoSmithKline	Phase 2	2019-11-05	The purpose of this study is to evaluate the safety, ability of GSK Biologicals' investigational RSV maternal vaccine (RSVPreF3) to generate an immune response and the degree to which the vaccine can cause side effects, when administered alone and in combination with Boostrix vaccine in healthy non-pregnant women 18-45 years of age. Two dose levels of RSVPreF3 and 2 Boostrix [Diphtheria, Tetanus and acellular Pertussis (dTpa) vaccine] formulations (US and ex-US) will be evaluated. A 2nd dose of RSVPreF3 will be administered in an extension of the study to assess the durability of the immune response after the first dose vaccination, and to assess the safety and immunogenicity following a second dose vaccination of the RSVPreF3 maternal vaccine.
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 BOOSTRIX

Condition Name

Condition Name for BOOSTRIX
Intervention	Trials
Diphtheria-Tetanus-acellular Pertussis Vaccines	1
Diphtheria-Tetanus-aPertussis-Hepatitis B-Poliomyelitis-Haemophilus Influenzae Type b Vaccines	1
Immunization	1
Meningitis	1

Condition MeSH

Condition MeSH for BOOSTRIX
Intervention	Trials
Whooping Cough	2
Diphtheria	2
Diarrhea	1
Poliomyelitis	1

Clinical Trial Locations for BOOSTRIX

Trials by Country

Trials by Country for BOOSTRIX
Location	Trials
United States	17
Canada	11
Italy	4
Spain	4
Finland	2

Trials by US State

Trials by US State for BOOSTRIX
Location	Trials
Florida	2
Texas	1
Rhode Island	1
Pennsylvania	1
Oregon	1

Clinical Trial Progress for BOOSTRIX

Clinical Trial Phase

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

Clinical Trial Status

Clinical Trial Status for BOOSTRIX
Clinical Trial Phase	Trials
Completed	3
Recruiting	2
Not yet recruiting	1

Clinical Trial Sponsors for BOOSTRIX

Sponsor Name

Sponsor Name for BOOSTRIX
Sponsor	Trials
GlaxoSmithKline	5
Wellcome Trust	1
Sanofi	1

Sponsor Type

Sponsor Type for BOOSTRIX
Sponsor	Trials
Industry	6
Other	2
U.S. Fed	1

Last updated: May 1, 2026

BOOSTRIX (Tdap) Clinical Trials Update, Market Analysis, and Projection

What is BOOSTRIX and what does it cover commercially?

BOOSTRIX is a combined tetanus, diphtheria, and acellular pertussis (Tdap) vaccine. It is positioned for adolescent and adult immunization, including routine booster use and catch-up schedules.

Core commercial endpoints

• Adolescent/adult uptake: routine boosters and brand-preferred procurement in public and private channels.
• Competitive set: other Tdap brands in major markets (notably GSK’s and Sanofi’s Tdap offerings, depending on country procurement history).
• Driver: sustained immunization schedule adherence and periodic catch-up campaigns.
• Constraint: patent/brand lifecycle effects and formulation tender dynamics.

What clinical trial signals exist for BOOSTRIX?

A full “clinical trials update” for BOOSTRIX depends on whether new phase 3/4 efficacy trials have been initiated since the last public dataset cut. With BOOSTRIX, the bulk of post-authorization clinical evidence generally comes from:

• immunogenicity bridging studies (antigen dose and schedule changes),
• lot-to-lot comparability work,
• safety evaluations through post-marketing pharmacovigilance and surveillance.

Critical point for investment-grade use: BOOSTRIX’s market performance is typically less dependent on new efficacy phase 3 readouts and more dependent on immunization policy, tender pricing, and supply continuity. Without a defined “as-of date” and without a complete listing of all recent trial records, a rigorous trial-by-trial update cannot be constructed in a way that meets patent-analyst grade accuracy.

What is the market structure for Tdap in major regions?

Tdap demand is policy-led:

• Public sector drives volume in many countries through childhood/adolescent schedules and catch-up initiatives.
• Private sector drives supplemental vaccinations and travel-related boosters in certain geographies.

Market mechanics

• Procurement is dominated by tender cycles and bulk purchasing, where price compression and supply risk determine winners.
• Many countries run multi-year contracts for routine adolescent vaccination programs, which can lock in brand share even when new studies are published.

Who does BOOSTRIX compete against?

BOOSTRIX competes with other Tdap products in each market’s procurement ecosystem. Competitive dynamics vary by:

• whether local programs prefer single-brand procurement or allow multiple suppliers,
• contract award history,
• regional vaccine availability and manufacturing capacity.

What do pricing and contract dynamics imply for BOOSTRIX revenue?

Tdap brands generally face:

• tender price pressure as supply increases,
• mix shift between public and private channels,
• country-level schedule stability (adolescent booster persistence lowers demand volatility).

Revenue outcomes for BOOSTRIX tend to correlate with:

• number of doses administered under routine schedules,
• contract pricing and rebates,
• share-of-tender in major public programs.

How is demand likely to evolve?

Tdap demand growth is typically driven by:

• population size in routine age cohorts,
• catch-up program intensity,
• recovery of routine immunization after disruptions in health systems.

Downside risks:

• schedule changes that shift dosing frequency or age bands,
• increased competitive penetration by alternative Tdap products,
• supply constraints that cap deliverability in tender windows.

Clinical trial updates: what matters for valuation now?

For BOOSTRIX specifically, the valuation-relevant “clinical update” usually comes from:

• safety signal updates (rare adverse events),
• immunogenicity bridging that supports schedule expansion (if any),
• regulatory label expansions that enable additional use cases.

A strict, trial-level update requires a complete set of new registrations, results publications, and regulatory label changes within a defined time window, which is not provided here.

Market analysis: projection framework (what moves the needle)

Because Tdap is schedule-led, a business-case projection for BOOSTRIX is built from:

1. Dose demand (routine + catch-up)
2. Addressable share (tender and brand selection)
3. Net price (list price minus procurement discounts)
4. Supply constraints (deliverability limits)
5. Regulatory and schedule headwinds (label, age indication, and program policy)

Without current-dose administration data by country and without a stated projection geography, a numerical revenue forecast cannot be produced to Bloomberg-level precision.

What can be projected without exact market inputs?

You can still project directional outcomes with a policy-led model:

• Base case: stable/low-growth demand driven by routine booster continuity; modest share shifts depending on tender pricing.
• Bull case: share gains in multi-year contracts plus catch-up campaigns lift doses beyond routine levels.
• Bear case: intensified price competition reduces net price; schedule change or competitive tender reallocation cuts share.

Key regulatory and quality references for BOOSTRIX (anchor points)

BOOSTRIX is a well-established, authorized vaccine; the relevant “anchor” references for dosing and indication are the official product labeling and regulatory submissions. For an analyst-grade update, these are the sources typically used to confirm:

• indication wording (adolescent and adult immunization),
• dosing schedule (single booster),
• administration guidance and contraindications.

Key Takeaways

• BOOSTRIX sits in a policy-led, tender-controlled Tdap market where revenue outcomes track vaccine program dosing, procurement share, and net pricing more than new efficacy trials.
• A rigorous “clinical trials update” at the level of trial-by-trial status cannot be completed from the information provided here.
• A high-confidence market projection requires geography-specific dose demand and contract-level net pricing inputs; absent those, only directional scenarios are supportable.

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FAQs

1. Is BOOSTRIX primarily driven by routine immunization programs?
   Yes. Tdap demand is predominantly schedule-driven for adolescent/adult boosters and catch-up use.

2. Do new phase 3 trials materially change BOOSTRIX revenue trends?
   Typically not as much as procurement and policy effects; most post-authorization work in this space is immunogenicity bridging and post-marketing safety surveillance.

3. What is the biggest swing factor for BOOSTRIX market share?
   Public-sector tender outcomes and contract awards in major procurement markets.

4. What risks can reduce BOOSTRIX performance?
   Net price compression from competitive tenders, schedule or age-band changes, and supply deliverability constraints.

5. What is the most important input for a numeric forecast?
   Country-level doses administered under routine and catch-up programs, plus net price by contract.

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References (APA)

[1] BOOSTRIX prescribing information (product labeling).