Trial Outcomes & Findings for Phase II Trial With Subcutaneous Immunotherapy in Patients Sensitized to Phleum Pratense (NCT NCT01567306)

Results Overview

Variation of the concentration of Phleum pratense extract needed to produce a positive nasal provocation test from baseline (V0) to final visit (FV). The changes will be compared among groups (including the placebo group).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

151 participants

Primary outcome timeframe

Baseline (V0) and Final Visit (FV). The Final Visit will be conducted within 7 plus minus 2 days after the last dose is administered. The study will be carried out outside the pollination season of Phleum pratense.

Results posted on

2019-04-29

Participant Flow

Participant milestones

Participant milestones
Measure	Allergovac Depot Group 1 Active Allergovac Depot: Increasing dosages till the maintenance dose of 0.25 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.	Allergovac Depot Group 2 Active Allergovac Depot: Increasing dosages till the maintenance dose of 0.5 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.	Allergovac Depot Group 3 Active Allergovac Depot: Increasing dosages till the maintenance dose of 1SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.	Allergovac Depot Group 4 Active Allergovac Depot: Increasing dosages till the maintenance dose of 2 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.	Allergovac Depot Group 5 Active Allergovac Depot: Increasing dosages till the maintenance dose of 4SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.	Placebo - Group 6 Placebo: Increasing volumes of placebo. Afterwards, 3 maintenance doses are given at 4-weekly intervals.
Overall Study STARTED	27	25	24	24	25	26
Overall Study COMPLETED	24	23	24	19	18	23
Overall Study NOT COMPLETED	3	2	0	5	7	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Allergovac Depot Group 1 Active Allergovac Depot: Increasing dosages till the maintenance dose of 0.25 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.	Allergovac Depot Group 2 Active Allergovac Depot: Increasing dosages till the maintenance dose of 0.5 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.	Allergovac Depot Group 4 Active Allergovac Depot: Increasing dosages till the maintenance dose of 2 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.	Allergovac Depot Group 5 Active Allergovac Depot: Increasing dosages till the maintenance dose of 4SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.	Placebo - Group 6 Placebo: Increasing volumes of placebo. Afterwards, 3 maintenance doses are given at 4-weekly intervals.
Overall Study Protocol Violation	2	2	3	1	1
Overall Study Change site living	1	0	0	0	0
Overall Study Adverse Event	0	0	2	4	1
Overall Study Lost to Follow-up	0	0	0	2	0
Overall Study Withdrawal by Subject	0	0	0	0	1

Baseline Characteristics

Phase II Trial With Subcutaneous Immunotherapy in Patients Sensitized to Phleum Pratense

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Allergovac Depot Group 1 Active n=27 Participants Allergovac Depot: Increasing dosages till the maintenance dose of 0.25 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.	Allergovac Depot Group 2 Active n=25 Participants Allergovac Depot: Increasing dosages till the maintenance dose of 0.5 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.	Allergovac Depot Group 3 Active n=24 Participants Allergovac Depot: Increasing dosages till the maintenance dose of 1SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.	Allergovac Depot Group 4 Active n=24 Participants Allergovac Depot: Increasing dosages till the maintenance dose of 2 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.	Allergovac Depot Group 5 Active n=25 Participants Allergovac Depot: Increasing dosages till the maintenance dose of 4SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.	Placebo - Group 6 n=26 Participants Placebo: Increasing volumes of placebo. Afterwards, 3 maintenance doses are given at 4-weekly intervals.	Total n=151 Participants Total of all reporting groups
Age, Continuous	27.4 years STANDARD_DEVIATION 7.7 • n=5 Participants	31.8 years STANDARD_DEVIATION 9.9 • n=7 Participants	34.8 years STANDARD_DEVIATION 9.0 • n=5 Participants	33.5 years STANDARD_DEVIATION 9.4 • n=4 Participants	34.9 years STANDARD_DEVIATION 8.3 • n=21 Participants	35.0 years STANDARD_DEVIATION 10 • n=10 Participants	32.9 years STANDARD_DEVIATION 9.0 • n=115 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	17 Participants n=7 Participants	16 Participants n=5 Participants	10 Participants n=4 Participants	12 Participants n=21 Participants	15 Participants n=10 Participants	88 Participants n=115 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	8 Participants n=7 Participants	8 Participants n=5 Participants	14 Participants n=4 Participants	13 Participants n=21 Participants	11 Participants n=10 Participants	63 Participants n=115 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=5 Participants	10 Participants n=7 Participants	9 Participants n=5 Participants	7 Participants n=4 Participants	8 Participants n=21 Participants	8 Participants n=10 Participants	54 Participants n=115 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants	15 Participants n=7 Participants	15 Participants n=5 Participants	17 Participants n=4 Participants	17 Participants n=21 Participants	18 Participants n=10 Participants	97 Participants n=115 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants

PRIMARY outcome

Timeframe: Baseline (V0) and Final Visit (FV). The Final Visit will be conducted within 7 plus minus 2 days after the last dose is administered. The study will be carried out outside the pollination season of Phleum pratense.

Population: Intent-to-treat population (ITT): This population included all randomized patients who received at least one treatment dose and who presented baseline and post-baseline values for the primary efficacy variable.

Variation of the concentration of Phleum pratense extract needed to produce a positive nasal provocation test from baseline (V0) to final visit (FV). The changes will be compared among groups (including the placebo group).

Outcome measures

Outcome measures
Measure	Allergovac Depot Group 1 Active n=25 Participants Allergovac Depot: Increasing dosages till the maintenance dose of 0.25 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.	Allergovac Depot Group 2 Active n=25 Participants Allergovac Depot: Increasing dosages till the maintenance dose of 0.5 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.	Allergovac Depot Group 3 Active n=24 Participants Allergovac Depot: Increasing dosages till the maintenance dose of 1SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.	Allergovac Depot Group 4 Active n=23 Participants Allergovac Depot: Increasing dosages till the maintenance dose of 2 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.	Allergovac Depot Group 5 Active n=23 Participants Allergovac Depot: Increasing dosages till the maintenance dose of 4SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.	Placebo - Group 6 n=23 Participants Placebo: Increasing volumes of placebo. Afterwards, 3 maintenance doses are given at 4-weekly intervals.
Variation of the Concentration of Phleum Pratense Extract Needed to Produce a Positive Nasal Provocation Test From Baseline (V0) to Final Visit (FV).	0.493 SPT Standard Deviation 2.060	0.275 SPT Standard Deviation 2.884	0.693 SPT Standard Deviation 2.142	0.876 SPT Standard Deviation 2.414	1.385 SPT Standard Deviation 2.170	0.839 SPT Standard Deviation 2.328

SECONDARY outcome

Timeframe: From baseline (V0) to final visit (VF). The Final Visit will be conducted within 7 plus minus 2 days after the last dose is administered. All AE should be monitored until they are satisfactorily resolved or stabilized after the final visit of the study

All adverse reactions and/or events were recorded both by the patient and the health care personnel responsible for the administration of the subcutaneous immunotherapy. The incidence and intensity of adverse events was compared among the treatment groups.

Outcome measures

Outcome data not reported

Adverse Events

Allergovac Depot Group 1 Active

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Allergovac Depot Group 2 Active

Serious events: 2 serious events

Other events: 15 other events

Deaths: 0 deaths

Allergovac Depot Group 3 Active

Serious events: 2 serious events

Other events: 7 other events

Deaths: 0 deaths

Allergovac Depot Group 4 Active

Serious events: 3 serious events

Other events: 3 other events

Deaths: 0 deaths

Allergovac Depot Group 5 Active

Serious events: 8 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo - Group 6

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Allergovac Depot Group 1 Active n=27 participants at risk Allergovac Depot: Increasing dosages till the maintenance dose of 0.25 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.	Allergovac Depot Group 2 Active n=25 participants at risk Allergovac Depot: Increasing dosages till the maintenance dose of 0.5 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.	Allergovac Depot Group 3 Active n=24 participants at risk Allergovac Depot: Increasing dosages till the maintenance dose of 1SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.	Allergovac Depot Group 4 Active n=24 participants at risk Allergovac Depot: Increasing dosages till the maintenance dose of 2 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.	Allergovac Depot Group 5 Active n=25 participants at risk Allergovac Depot: Increasing dosages till the maintenance dose of 4SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.	Placebo - Group 6 n=26 participants at risk Placebo: Increasing volumes of placebo. Afterwards, 3 maintenance doses are given at 4-weekly intervals.
Skin and subcutaneous tissue disorders Generalized urticaria	0.00% 0/27 • For each participant in the research, the treatment duration was established at 17 weeks, of which 5 weeks were needed for the induction phase and the other 12 weeks were for treatment at the maintenance dose. During this period adverse event data were collected. Any unfavorable medical occurrence, including any abnormal sign (for example, abnormal physical exam), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participation in the research. Adverse reactions were classified as local or systemic in relation to where the reaction appeared. Local reactions appeared in the same place of administration and systemic reactions occurred far from the administration point.	4.0% 1/25 • Number of events 1 • For each participant in the research, the treatment duration was established at 17 weeks, of which 5 weeks were needed for the induction phase and the other 12 weeks were for treatment at the maintenance dose. During this period adverse event data were collected. Any unfavorable medical occurrence, including any abnormal sign (for example, abnormal physical exam), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participation in the research. Adverse reactions were classified as local or systemic in relation to where the reaction appeared. Local reactions appeared in the same place of administration and systemic reactions occurred far from the administration point.	8.3% 2/24 • Number of events 2 • For each participant in the research, the treatment duration was established at 17 weeks, of which 5 weeks were needed for the induction phase and the other 12 weeks were for treatment at the maintenance dose. During this period adverse event data were collected. Any unfavorable medical occurrence, including any abnormal sign (for example, abnormal physical exam), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participation in the research. Adverse reactions were classified as local or systemic in relation to where the reaction appeared. Local reactions appeared in the same place of administration and systemic reactions occurred far from the administration point.	8.3% 2/24 • Number of events 2 • For each participant in the research, the treatment duration was established at 17 weeks, of which 5 weeks were needed for the induction phase and the other 12 weeks were for treatment at the maintenance dose. During this period adverse event data were collected. Any unfavorable medical occurrence, including any abnormal sign (for example, abnormal physical exam), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participation in the research. Adverse reactions were classified as local or systemic in relation to where the reaction appeared. Local reactions appeared in the same place of administration and systemic reactions occurred far from the administration point.	16.0% 4/25 • Number of events 4 • For each participant in the research, the treatment duration was established at 17 weeks, of which 5 weeks were needed for the induction phase and the other 12 weeks were for treatment at the maintenance dose. During this period adverse event data were collected. Any unfavorable medical occurrence, including any abnormal sign (for example, abnormal physical exam), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participation in the research. Adverse reactions were classified as local or systemic in relation to where the reaction appeared. Local reactions appeared in the same place of administration and systemic reactions occurred far from the administration point.	0.00% 0/26 • For each participant in the research, the treatment duration was established at 17 weeks, of which 5 weeks were needed for the induction phase and the other 12 weeks were for treatment at the maintenance dose. During this period adverse event data were collected. Any unfavorable medical occurrence, including any abnormal sign (for example, abnormal physical exam), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participation in the research. Adverse reactions were classified as local or systemic in relation to where the reaction appeared. Local reactions appeared in the same place of administration and systemic reactions occurred far from the administration point.
Immune system disorders anaphylaxis	0.00% 0/27 • For each participant in the research, the treatment duration was established at 17 weeks, of which 5 weeks were needed for the induction phase and the other 12 weeks were for treatment at the maintenance dose. During this period adverse event data were collected. Any unfavorable medical occurrence, including any abnormal sign (for example, abnormal physical exam), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participation in the research. Adverse reactions were classified as local or systemic in relation to where the reaction appeared. Local reactions appeared in the same place of administration and systemic reactions occurred far from the administration point.	0.00% 0/25 • For each participant in the research, the treatment duration was established at 17 weeks, of which 5 weeks were needed for the induction phase and the other 12 weeks were for treatment at the maintenance dose. During this period adverse event data were collected. Any unfavorable medical occurrence, including any abnormal sign (for example, abnormal physical exam), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participation in the research. Adverse reactions were classified as local or systemic in relation to where the reaction appeared. Local reactions appeared in the same place of administration and systemic reactions occurred far from the administration point.	0.00% 0/24 • For each participant in the research, the treatment duration was established at 17 weeks, of which 5 weeks were needed for the induction phase and the other 12 weeks were for treatment at the maintenance dose. During this period adverse event data were collected. Any unfavorable medical occurrence, including any abnormal sign (for example, abnormal physical exam), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participation in the research. Adverse reactions were classified as local or systemic in relation to where the reaction appeared. Local reactions appeared in the same place of administration and systemic reactions occurred far from the administration point.	4.2% 1/24 • Number of events 1 • For each participant in the research, the treatment duration was established at 17 weeks, of which 5 weeks were needed for the induction phase and the other 12 weeks were for treatment at the maintenance dose. During this period adverse event data were collected. Any unfavorable medical occurrence, including any abnormal sign (for example, abnormal physical exam), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participation in the research. Adverse reactions were classified as local or systemic in relation to where the reaction appeared. Local reactions appeared in the same place of administration and systemic reactions occurred far from the administration point.	8.0% 2/25 • Number of events 2 • For each participant in the research, the treatment duration was established at 17 weeks, of which 5 weeks were needed for the induction phase and the other 12 weeks were for treatment at the maintenance dose. During this period adverse event data were collected. Any unfavorable medical occurrence, including any abnormal sign (for example, abnormal physical exam), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participation in the research. Adverse reactions were classified as local or systemic in relation to where the reaction appeared. Local reactions appeared in the same place of administration and systemic reactions occurred far from the administration point.	0.00% 0/26 • For each participant in the research, the treatment duration was established at 17 weeks, of which 5 weeks were needed for the induction phase and the other 12 weeks were for treatment at the maintenance dose. During this period adverse event data were collected. Any unfavorable medical occurrence, including any abnormal sign (for example, abnormal physical exam), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participation in the research. Adverse reactions were classified as local or systemic in relation to where the reaction appeared. Local reactions appeared in the same place of administration and systemic reactions occurred far from the administration point.
Skin and subcutaneous tissue disorders cutaneous pruritus	3.7% 1/27 • Number of events 1 • For each participant in the research, the treatment duration was established at 17 weeks, of which 5 weeks were needed for the induction phase and the other 12 weeks were for treatment at the maintenance dose. During this period adverse event data were collected. Any unfavorable medical occurrence, including any abnormal sign (for example, abnormal physical exam), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participation in the research. Adverse reactions were classified as local or systemic in relation to where the reaction appeared. Local reactions appeared in the same place of administration and systemic reactions occurred far from the administration point.	0.00% 0/25 • For each participant in the research, the treatment duration was established at 17 weeks, of which 5 weeks were needed for the induction phase and the other 12 weeks were for treatment at the maintenance dose. During this period adverse event data were collected. Any unfavorable medical occurrence, including any abnormal sign (for example, abnormal physical exam), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participation in the research. Adverse reactions were classified as local or systemic in relation to where the reaction appeared. Local reactions appeared in the same place of administration and systemic reactions occurred far from the administration point.	0.00% 0/24 • For each participant in the research, the treatment duration was established at 17 weeks, of which 5 weeks were needed for the induction phase and the other 12 weeks were for treatment at the maintenance dose. During this period adverse event data were collected. Any unfavorable medical occurrence, including any abnormal sign (for example, abnormal physical exam), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participation in the research. Adverse reactions were classified as local or systemic in relation to where the reaction appeared. Local reactions appeared in the same place of administration and systemic reactions occurred far from the administration point.	0.00% 0/24 • For each participant in the research, the treatment duration was established at 17 weeks, of which 5 weeks were needed for the induction phase and the other 12 weeks were for treatment at the maintenance dose. During this period adverse event data were collected. Any unfavorable medical occurrence, including any abnormal sign (for example, abnormal physical exam), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participation in the research. Adverse reactions were classified as local or systemic in relation to where the reaction appeared. Local reactions appeared in the same place of administration and systemic reactions occurred far from the administration point.	4.0% 1/25 • Number of events 1 • For each participant in the research, the treatment duration was established at 17 weeks, of which 5 weeks were needed for the induction phase and the other 12 weeks were for treatment at the maintenance dose. During this period adverse event data were collected. Any unfavorable medical occurrence, including any abnormal sign (for example, abnormal physical exam), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participation in the research. Adverse reactions were classified as local or systemic in relation to where the reaction appeared. Local reactions appeared in the same place of administration and systemic reactions occurred far from the administration point.	0.00% 0/26 • For each participant in the research, the treatment duration was established at 17 weeks, of which 5 weeks were needed for the induction phase and the other 12 weeks were for treatment at the maintenance dose. During this period adverse event data were collected. Any unfavorable medical occurrence, including any abnormal sign (for example, abnormal physical exam), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participation in the research. Adverse reactions were classified as local or systemic in relation to where the reaction appeared. Local reactions appeared in the same place of administration and systemic reactions occurred far from the administration point.
Skin and subcutaneous tissue disorders urticaria	0.00% 0/27 • For each participant in the research, the treatment duration was established at 17 weeks, of which 5 weeks were needed for the induction phase and the other 12 weeks were for treatment at the maintenance dose. During this period adverse event data were collected. Any unfavorable medical occurrence, including any abnormal sign (for example, abnormal physical exam), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participation in the research. Adverse reactions were classified as local or systemic in relation to where the reaction appeared. Local reactions appeared in the same place of administration and systemic reactions occurred far from the administration point.	0.00% 0/25 • For each participant in the research, the treatment duration was established at 17 weeks, of which 5 weeks were needed for the induction phase and the other 12 weeks were for treatment at the maintenance dose. During this period adverse event data were collected. Any unfavorable medical occurrence, including any abnormal sign (for example, abnormal physical exam), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participation in the research. Adverse reactions were classified as local or systemic in relation to where the reaction appeared. Local reactions appeared in the same place of administration and systemic reactions occurred far from the administration point.	0.00% 0/24 • For each participant in the research, the treatment duration was established at 17 weeks, of which 5 weeks were needed for the induction phase and the other 12 weeks were for treatment at the maintenance dose. During this period adverse event data were collected. Any unfavorable medical occurrence, including any abnormal sign (for example, abnormal physical exam), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participation in the research. Adverse reactions were classified as local or systemic in relation to where the reaction appeared. Local reactions appeared in the same place of administration and systemic reactions occurred far from the administration point.	0.00% 0/24 • For each participant in the research, the treatment duration was established at 17 weeks, of which 5 weeks were needed for the induction phase and the other 12 weeks were for treatment at the maintenance dose. During this period adverse event data were collected. Any unfavorable medical occurrence, including any abnormal sign (for example, abnormal physical exam), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participation in the research. Adverse reactions were classified as local or systemic in relation to where the reaction appeared. Local reactions appeared in the same place of administration and systemic reactions occurred far from the administration point.	4.0% 1/25 • Number of events 1 • For each participant in the research, the treatment duration was established at 17 weeks, of which 5 weeks were needed for the induction phase and the other 12 weeks were for treatment at the maintenance dose. During this period adverse event data were collected. Any unfavorable medical occurrence, including any abnormal sign (for example, abnormal physical exam), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participation in the research. Adverse reactions were classified as local or systemic in relation to where the reaction appeared. Local reactions appeared in the same place of administration and systemic reactions occurred far from the administration point.	0.00% 0/26 • For each participant in the research, the treatment duration was established at 17 weeks, of which 5 weeks were needed for the induction phase and the other 12 weeks were for treatment at the maintenance dose. During this period adverse event data were collected. Any unfavorable medical occurrence, including any abnormal sign (for example, abnormal physical exam), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participation in the research. Adverse reactions were classified as local or systemic in relation to where the reaction appeared. Local reactions appeared in the same place of administration and systemic reactions occurred far from the administration point.
Skin and subcutaneous tissue disorders generalized pruritus	0.00% 0/27 • For each participant in the research, the treatment duration was established at 17 weeks, of which 5 weeks were needed for the induction phase and the other 12 weeks were for treatment at the maintenance dose. During this period adverse event data were collected. Any unfavorable medical occurrence, including any abnormal sign (for example, abnormal physical exam), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participation in the research. Adverse reactions were classified as local or systemic in relation to where the reaction appeared. Local reactions appeared in the same place of administration and systemic reactions occurred far from the administration point.	4.0% 1/25 • Number of events 1 • For each participant in the research, the treatment duration was established at 17 weeks, of which 5 weeks were needed for the induction phase and the other 12 weeks were for treatment at the maintenance dose. During this period adverse event data were collected. Any unfavorable medical occurrence, including any abnormal sign (for example, abnormal physical exam), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participation in the research. Adverse reactions were classified as local or systemic in relation to where the reaction appeared. Local reactions appeared in the same place of administration and systemic reactions occurred far from the administration point.	0.00% 0/24 • For each participant in the research, the treatment duration was established at 17 weeks, of which 5 weeks were needed for the induction phase and the other 12 weeks were for treatment at the maintenance dose. During this period adverse event data were collected. Any unfavorable medical occurrence, including any abnormal sign (for example, abnormal physical exam), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participation in the research. Adverse reactions were classified as local or systemic in relation to where the reaction appeared. Local reactions appeared in the same place of administration and systemic reactions occurred far from the administration point.	0.00% 0/24 • For each participant in the research, the treatment duration was established at 17 weeks, of which 5 weeks were needed for the induction phase and the other 12 weeks were for treatment at the maintenance dose. During this period adverse event data were collected. Any unfavorable medical occurrence, including any abnormal sign (for example, abnormal physical exam), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participation in the research. Adverse reactions were classified as local or systemic in relation to where the reaction appeared. Local reactions appeared in the same place of administration and systemic reactions occurred far from the administration point.	4.0% 1/25 • Number of events 1 • For each participant in the research, the treatment duration was established at 17 weeks, of which 5 weeks were needed for the induction phase and the other 12 weeks were for treatment at the maintenance dose. During this period adverse event data were collected. Any unfavorable medical occurrence, including any abnormal sign (for example, abnormal physical exam), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participation in the research. Adverse reactions were classified as local or systemic in relation to where the reaction appeared. Local reactions appeared in the same place of administration and systemic reactions occurred far from the administration point.	0.00% 0/26 • For each participant in the research, the treatment duration was established at 17 weeks, of which 5 weeks were needed for the induction phase and the other 12 weeks were for treatment at the maintenance dose. During this period adverse event data were collected. Any unfavorable medical occurrence, including any abnormal sign (for example, abnormal physical exam), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participation in the research. Adverse reactions were classified as local or systemic in relation to where the reaction appeared. Local reactions appeared in the same place of administration and systemic reactions occurred far from the administration point.
Musculoskeletal and connective tissue disorders hand fracture	0.00% 0/27 • For each participant in the research, the treatment duration was established at 17 weeks, of which 5 weeks were needed for the induction phase and the other 12 weeks were for treatment at the maintenance dose. During this period adverse event data were collected. Any unfavorable medical occurrence, including any abnormal sign (for example, abnormal physical exam), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participation in the research. Adverse reactions were classified as local or systemic in relation to where the reaction appeared. Local reactions appeared in the same place of administration and systemic reactions occurred far from the administration point.	0.00% 0/25 • For each participant in the research, the treatment duration was established at 17 weeks, of which 5 weeks were needed for the induction phase and the other 12 weeks were for treatment at the maintenance dose. During this period adverse event data were collected. Any unfavorable medical occurrence, including any abnormal sign (for example, abnormal physical exam), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participation in the research. Adverse reactions were classified as local or systemic in relation to where the reaction appeared. Local reactions appeared in the same place of administration and systemic reactions occurred far from the administration point.	0.00% 0/24 • For each participant in the research, the treatment duration was established at 17 weeks, of which 5 weeks were needed for the induction phase and the other 12 weeks were for treatment at the maintenance dose. During this period adverse event data were collected. Any unfavorable medical occurrence, including any abnormal sign (for example, abnormal physical exam), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participation in the research. Adverse reactions were classified as local or systemic in relation to where the reaction appeared. Local reactions appeared in the same place of administration and systemic reactions occurred far from the administration point.	0.00% 0/24 • For each participant in the research, the treatment duration was established at 17 weeks, of which 5 weeks were needed for the induction phase and the other 12 weeks were for treatment at the maintenance dose. During this period adverse event data were collected. Any unfavorable medical occurrence, including any abnormal sign (for example, abnormal physical exam), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participation in the research. Adverse reactions were classified as local or systemic in relation to where the reaction appeared. Local reactions appeared in the same place of administration and systemic reactions occurred far from the administration point.	4.0% 1/25 • Number of events 1 • For each participant in the research, the treatment duration was established at 17 weeks, of which 5 weeks were needed for the induction phase and the other 12 weeks were for treatment at the maintenance dose. During this period adverse event data were collected. Any unfavorable medical occurrence, including any abnormal sign (for example, abnormal physical exam), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participation in the research. Adverse reactions were classified as local or systemic in relation to where the reaction appeared. Local reactions appeared in the same place of administration and systemic reactions occurred far from the administration point.	0.00% 0/26 • For each participant in the research, the treatment duration was established at 17 weeks, of which 5 weeks were needed for the induction phase and the other 12 weeks were for treatment at the maintenance dose. During this period adverse event data were collected. Any unfavorable medical occurrence, including any abnormal sign (for example, abnormal physical exam), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participation in the research. Adverse reactions were classified as local or systemic in relation to where the reaction appeared. Local reactions appeared in the same place of administration and systemic reactions occurred far from the administration point.
Vascular disorders deep vein thrombosis	0.00% 0/27 • For each participant in the research, the treatment duration was established at 17 weeks, of which 5 weeks were needed for the induction phase and the other 12 weeks were for treatment at the maintenance dose. During this period adverse event data were collected. Any unfavorable medical occurrence, including any abnormal sign (for example, abnormal physical exam), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participation in the research. Adverse reactions were classified as local or systemic in relation to where the reaction appeared. Local reactions appeared in the same place of administration and systemic reactions occurred far from the administration point.	0.00% 0/25 • For each participant in the research, the treatment duration was established at 17 weeks, of which 5 weeks were needed for the induction phase and the other 12 weeks were for treatment at the maintenance dose. During this period adverse event data were collected. Any unfavorable medical occurrence, including any abnormal sign (for example, abnormal physical exam), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participation in the research. Adverse reactions were classified as local or systemic in relation to where the reaction appeared. Local reactions appeared in the same place of administration and systemic reactions occurred far from the administration point.	0.00% 0/24 • For each participant in the research, the treatment duration was established at 17 weeks, of which 5 weeks were needed for the induction phase and the other 12 weeks were for treatment at the maintenance dose. During this period adverse event data were collected. Any unfavorable medical occurrence, including any abnormal sign (for example, abnormal physical exam), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participation in the research. Adverse reactions were classified as local or systemic in relation to where the reaction appeared. Local reactions appeared in the same place of administration and systemic reactions occurred far from the administration point.	0.00% 0/24 • For each participant in the research, the treatment duration was established at 17 weeks, of which 5 weeks were needed for the induction phase and the other 12 weeks were for treatment at the maintenance dose. During this period adverse event data were collected. Any unfavorable medical occurrence, including any abnormal sign (for example, abnormal physical exam), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participation in the research. Adverse reactions were classified as local or systemic in relation to where the reaction appeared. Local reactions appeared in the same place of administration and systemic reactions occurred far from the administration point.	0.00% 0/25 • For each participant in the research, the treatment duration was established at 17 weeks, of which 5 weeks were needed for the induction phase and the other 12 weeks were for treatment at the maintenance dose. During this period adverse event data were collected. Any unfavorable medical occurrence, including any abnormal sign (for example, abnormal physical exam), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participation in the research. Adverse reactions were classified as local or systemic in relation to where the reaction appeared. Local reactions appeared in the same place of administration and systemic reactions occurred far from the administration point.	3.8% 1/26 • Number of events 1 • For each participant in the research, the treatment duration was established at 17 weeks, of which 5 weeks were needed for the induction phase and the other 12 weeks were for treatment at the maintenance dose. During this period adverse event data were collected. Any unfavorable medical occurrence, including any abnormal sign (for example, abnormal physical exam), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participation in the research. Adverse reactions were classified as local or systemic in relation to where the reaction appeared. Local reactions appeared in the same place of administration and systemic reactions occurred far from the administration point.

Other adverse events

Other adverse events
Measure	Allergovac Depot Group 1 Active n=27 participants at risk Allergovac Depot: Increasing dosages till the maintenance dose of 0.25 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.	Allergovac Depot Group 2 Active n=25 participants at risk Allergovac Depot: Increasing dosages till the maintenance dose of 0.5 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.	Allergovac Depot Group 3 Active n=24 participants at risk Allergovac Depot: Increasing dosages till the maintenance dose of 1SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.	Allergovac Depot Group 4 Active n=24 participants at risk Allergovac Depot: Increasing dosages till the maintenance dose of 2 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.	Allergovac Depot Group 5 Active n=25 participants at risk Allergovac Depot: Increasing dosages till the maintenance dose of 4SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.	Placebo - Group 6 n=26 participants at risk Placebo: Increasing volumes of placebo. Afterwards, 3 maintenance doses are given at 4-weekly intervals.
Infections and infestations nasopharyngitis	22.2% 6/27 • Number of events 7 • For each participant in the research, the treatment duration was established at 17 weeks, of which 5 weeks were needed for the induction phase and the other 12 weeks were for treatment at the maintenance dose. During this period adverse event data were collected. Any unfavorable medical occurrence, including any abnormal sign (for example, abnormal physical exam), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participation in the research. Adverse reactions were classified as local or systemic in relation to where the reaction appeared. Local reactions appeared in the same place of administration and systemic reactions occurred far from the administration point.	20.0% 5/25 • Number of events 7 • For each participant in the research, the treatment duration was established at 17 weeks, of which 5 weeks were needed for the induction phase and the other 12 weeks were for treatment at the maintenance dose. During this period adverse event data were collected. Any unfavorable medical occurrence, including any abnormal sign (for example, abnormal physical exam), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participation in the research. Adverse reactions were classified as local or systemic in relation to where the reaction appeared. Local reactions appeared in the same place of administration and systemic reactions occurred far from the administration point.	12.5% 3/24 • Number of events 4 • For each participant in the research, the treatment duration was established at 17 weeks, of which 5 weeks were needed for the induction phase and the other 12 weeks were for treatment at the maintenance dose. During this period adverse event data were collected. Any unfavorable medical occurrence, including any abnormal sign (for example, abnormal physical exam), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participation in the research. Adverse reactions were classified as local or systemic in relation to where the reaction appeared. Local reactions appeared in the same place of administration and systemic reactions occurred far from the administration point.	4.2% 1/24 • Number of events 1 • For each participant in the research, the treatment duration was established at 17 weeks, of which 5 weeks were needed for the induction phase and the other 12 weeks were for treatment at the maintenance dose. During this period adverse event data were collected. Any unfavorable medical occurrence, including any abnormal sign (for example, abnormal physical exam), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participation in the research. Adverse reactions were classified as local or systemic in relation to where the reaction appeared. Local reactions appeared in the same place of administration and systemic reactions occurred far from the administration point.	4.0% 1/25 • Number of events 1 • For each participant in the research, the treatment duration was established at 17 weeks, of which 5 weeks were needed for the induction phase and the other 12 weeks were for treatment at the maintenance dose. During this period adverse event data were collected. Any unfavorable medical occurrence, including any abnormal sign (for example, abnormal physical exam), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participation in the research. Adverse reactions were classified as local or systemic in relation to where the reaction appeared. Local reactions appeared in the same place of administration and systemic reactions occurred far from the administration point.	11.5% 3/26 • Number of events 3 • For each participant in the research, the treatment duration was established at 17 weeks, of which 5 weeks were needed for the induction phase and the other 12 weeks were for treatment at the maintenance dose. During this period adverse event data were collected. Any unfavorable medical occurrence, including any abnormal sign (for example, abnormal physical exam), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participation in the research. Adverse reactions were classified as local or systemic in relation to where the reaction appeared. Local reactions appeared in the same place of administration and systemic reactions occurred far from the administration point.
Nervous system disorders headache	3.7% 1/27 • Number of events 1 • For each participant in the research, the treatment duration was established at 17 weeks, of which 5 weeks were needed for the induction phase and the other 12 weeks were for treatment at the maintenance dose. During this period adverse event data were collected. Any unfavorable medical occurrence, including any abnormal sign (for example, abnormal physical exam), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participation in the research. Adverse reactions were classified as local or systemic in relation to where the reaction appeared. Local reactions appeared in the same place of administration and systemic reactions occurred far from the administration point.	24.0% 6/25 • Number of events 9 • For each participant in the research, the treatment duration was established at 17 weeks, of which 5 weeks were needed for the induction phase and the other 12 weeks were for treatment at the maintenance dose. During this period adverse event data were collected. Any unfavorable medical occurrence, including any abnormal sign (for example, abnormal physical exam), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participation in the research. Adverse reactions were classified as local or systemic in relation to where the reaction appeared. Local reactions appeared in the same place of administration and systemic reactions occurred far from the administration point.	16.7% 4/24 • Number of events 9 • For each participant in the research, the treatment duration was established at 17 weeks, of which 5 weeks were needed for the induction phase and the other 12 weeks were for treatment at the maintenance dose. During this period adverse event data were collected. Any unfavorable medical occurrence, including any abnormal sign (for example, abnormal physical exam), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participation in the research. Adverse reactions were classified as local or systemic in relation to where the reaction appeared. Local reactions appeared in the same place of administration and systemic reactions occurred far from the administration point.	4.2% 1/24 • Number of events 1 • For each participant in the research, the treatment duration was established at 17 weeks, of which 5 weeks were needed for the induction phase and the other 12 weeks were for treatment at the maintenance dose. During this period adverse event data were collected. Any unfavorable medical occurrence, including any abnormal sign (for example, abnormal physical exam), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participation in the research. Adverse reactions were classified as local or systemic in relation to where the reaction appeared. Local reactions appeared in the same place of administration and systemic reactions occurred far from the administration point.	4.0% 1/25 • Number of events 1 • For each participant in the research, the treatment duration was established at 17 weeks, of which 5 weeks were needed for the induction phase and the other 12 weeks were for treatment at the maintenance dose. During this period adverse event data were collected. Any unfavorable medical occurrence, including any abnormal sign (for example, abnormal physical exam), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participation in the research. Adverse reactions were classified as local or systemic in relation to where the reaction appeared. Local reactions appeared in the same place of administration and systemic reactions occurred far from the administration point.	3.8% 1/26 • Number of events 1 • For each participant in the research, the treatment duration was established at 17 weeks, of which 5 weeks were needed for the induction phase and the other 12 weeks were for treatment at the maintenance dose. During this period adverse event data were collected. Any unfavorable medical occurrence, including any abnormal sign (for example, abnormal physical exam), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participation in the research. Adverse reactions were classified as local or systemic in relation to where the reaction appeared. Local reactions appeared in the same place of administration and systemic reactions occurred far from the administration point.
Respiratory, thoracic and mediastinal disorders rhinitis allergic	3.7% 1/27 • Number of events 4 • For each participant in the research, the treatment duration was established at 17 weeks, of which 5 weeks were needed for the induction phase and the other 12 weeks were for treatment at the maintenance dose. During this period adverse event data were collected. Any unfavorable medical occurrence, including any abnormal sign (for example, abnormal physical exam), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participation in the research. Adverse reactions were classified as local or systemic in relation to where the reaction appeared. Local reactions appeared in the same place of administration and systemic reactions occurred far from the administration point.	8.0% 2/25 • Number of events 2 • For each participant in the research, the treatment duration was established at 17 weeks, of which 5 weeks were needed for the induction phase and the other 12 weeks were for treatment at the maintenance dose. During this period adverse event data were collected. Any unfavorable medical occurrence, including any abnormal sign (for example, abnormal physical exam), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participation in the research. Adverse reactions were classified as local or systemic in relation to where the reaction appeared. Local reactions appeared in the same place of administration and systemic reactions occurred far from the administration point.	0.00% 0/24 • For each participant in the research, the treatment duration was established at 17 weeks, of which 5 weeks were needed for the induction phase and the other 12 weeks were for treatment at the maintenance dose. During this period adverse event data were collected. Any unfavorable medical occurrence, including any abnormal sign (for example, abnormal physical exam), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participation in the research. Adverse reactions were classified as local or systemic in relation to where the reaction appeared. Local reactions appeared in the same place of administration and systemic reactions occurred far from the administration point.	4.2% 1/24 • Number of events 1 • For each participant in the research, the treatment duration was established at 17 weeks, of which 5 weeks were needed for the induction phase and the other 12 weeks were for treatment at the maintenance dose. During this period adverse event data were collected. Any unfavorable medical occurrence, including any abnormal sign (for example, abnormal physical exam), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participation in the research. Adverse reactions were classified as local or systemic in relation to where the reaction appeared. Local reactions appeared in the same place of administration and systemic reactions occurred far from the administration point.	4.0% 1/25 • Number of events 3 • For each participant in the research, the treatment duration was established at 17 weeks, of which 5 weeks were needed for the induction phase and the other 12 weeks were for treatment at the maintenance dose. During this period adverse event data were collected. Any unfavorable medical occurrence, including any abnormal sign (for example, abnormal physical exam), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participation in the research. Adverse reactions were classified as local or systemic in relation to where the reaction appeared. Local reactions appeared in the same place of administration and systemic reactions occurred far from the administration point.	0.00% 0/26 • For each participant in the research, the treatment duration was established at 17 weeks, of which 5 weeks were needed for the induction phase and the other 12 weeks were for treatment at the maintenance dose. During this period adverse event data were collected. Any unfavorable medical occurrence, including any abnormal sign (for example, abnormal physical exam), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participation in the research. Adverse reactions were classified as local or systemic in relation to where the reaction appeared. Local reactions appeared in the same place of administration and systemic reactions occurred far from the administration point.
Respiratory, thoracic and mediastinal disorders rhinorrhoea	0.00% 0/27 • For each participant in the research, the treatment duration was established at 17 weeks, of which 5 weeks were needed for the induction phase and the other 12 weeks were for treatment at the maintenance dose. During this period adverse event data were collected. Any unfavorable medical occurrence, including any abnormal sign (for example, abnormal physical exam), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participation in the research. Adverse reactions were classified as local or systemic in relation to where the reaction appeared. Local reactions appeared in the same place of administration and systemic reactions occurred far from the administration point.	8.0% 2/25 • Number of events 2 • For each participant in the research, the treatment duration was established at 17 weeks, of which 5 weeks were needed for the induction phase and the other 12 weeks were for treatment at the maintenance dose. During this period adverse event data were collected. Any unfavorable medical occurrence, including any abnormal sign (for example, abnormal physical exam), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participation in the research. Adverse reactions were classified as local or systemic in relation to where the reaction appeared. Local reactions appeared in the same place of administration and systemic reactions occurred far from the administration point.	0.00% 0/24 • For each participant in the research, the treatment duration was established at 17 weeks, of which 5 weeks were needed for the induction phase and the other 12 weeks were for treatment at the maintenance dose. During this period adverse event data were collected. Any unfavorable medical occurrence, including any abnormal sign (for example, abnormal physical exam), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participation in the research. Adverse reactions were classified as local or systemic in relation to where the reaction appeared. Local reactions appeared in the same place of administration and systemic reactions occurred far from the administration point.	0.00% 0/24 • For each participant in the research, the treatment duration was established at 17 weeks, of which 5 weeks were needed for the induction phase and the other 12 weeks were for treatment at the maintenance dose. During this period adverse event data were collected. Any unfavorable medical occurrence, including any abnormal sign (for example, abnormal physical exam), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participation in the research. Adverse reactions were classified as local or systemic in relation to where the reaction appeared. Local reactions appeared in the same place of administration and systemic reactions occurred far from the administration point.	0.00% 0/25 • For each participant in the research, the treatment duration was established at 17 weeks, of which 5 weeks were needed for the induction phase and the other 12 weeks were for treatment at the maintenance dose. During this period adverse event data were collected. Any unfavorable medical occurrence, including any abnormal sign (for example, abnormal physical exam), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participation in the research. Adverse reactions were classified as local or systemic in relation to where the reaction appeared. Local reactions appeared in the same place of administration and systemic reactions occurred far from the administration point.	0.00% 0/26 • For each participant in the research, the treatment duration was established at 17 weeks, of which 5 weeks were needed for the induction phase and the other 12 weeks were for treatment at the maintenance dose. During this period adverse event data were collected. Any unfavorable medical occurrence, including any abnormal sign (for example, abnormal physical exam), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participation in the research. Adverse reactions were classified as local or systemic in relation to where the reaction appeared. Local reactions appeared in the same place of administration and systemic reactions occurred far from the administration point.

Additional Information

Dr. M Cruz Gómez project manager of Roxall Medicina España S.A.

Roxall Medicina España S.A.

Phone: +34 944438000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place