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Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Tablets in Children Suffering From Grass Pollen Rhinoconjunctivitis

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Stallergenes Greer

Status and phase

Completed
Phase 3

Conditions

Allergy

Treatments

Drug: 300 IR grass pollen allergen extract tablet
Drug: Placebo tablet

Study type

Interventional

Funder types

Industry

Identifiers

NCT00409409
VO52.06

Details and patient eligibility

About

A phase III study to evaluate the efficacy and safety of SLIT for grass pollen allergens compared with placebo for reduction of symptoms and rescue medication usage in children.

Enrollment

278 patients

Sex

All

Ages

5 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Male or female outpatients aged 5 to 17 years.
  • Written consent / assent.
  • Grass pollen-related allergic rhinoconjunctivitis for at least the last two pollen seasons.
  • Sensitised to grass pollen (positive SPT and grass pollen-specific IgE values of at least Class 2).
  • Total symptom score on the Retrospective RTSS during the previous pollen season of greater than or equal to 12.

Exclusion criteria

  • Patients who have received any desensitisation treatment for grass pollen.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

278 participants in 2 patient groups, including a placebo group

300 IR
Experimental group
Description:
300 IR grass pollen allergen extract tablet
Treatment:
Drug: 300 IR grass pollen allergen extract tablet
Placebo
Placebo Comparator group
Description:
Placebo tablet
Treatment:
Drug: Placebo tablet

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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